Method Of Sterilizing Medical Devices, Analyzing Biological Indicators, And Linking Medical Device Sterilization Equipment

ABSTRACT

A biological indicator analyzer includes a plurality of wells, a plurality of organism detector features, and a user input feature such as a touch screen. Each well is configured to receive a respective biological indicator. Each organism detector feature is configured to detect whether a biological indicator disposed in a corresponding well of the plurality of wells contains a living organism. The touch screen is configured to receive user input and provide information to the user indicating a status of biological indicator analysis. The biological indicator analyzer may be used to analyze a biological indicator that was positioned in a sterilization chamber of a sterilizing cabinet along with at least one medical device that is to be sterilized. The analysis may indicate whether the sterilization cycle in the sterilization chamber as successful.

PRIORITY

This application is a continuation of U.S. patent application Ser. No.16/786,276, entitled “Method of Sterilizing Medical Devices, AnalyzingBiological Indicators, and Linking Medical Device SterilizationEquipment,” filed on Feb. 10, 2020, which is a continuation of U.S.patent application Ser. No. 15/441,786, entitled “Method of SterilizingMedical Devices, Analyzing Biological Indicators, and Linking MedicalDevice Sterilization Equipment,” filed on Feb. 24, 2017, and issued asU.S. Pat. No. 10,561,753 on Feb. 18, 2020, the disclosures of which areincorporated herein by reference.

This application claims priority to U.S. Provisional Patent ApplicationNo. 62/302,257, entitled “System and Method for Sterilizing MedicalDevices,” filed on Mar. 2, 2016, the disclosure of which is incorporatedby reference herein.

This application also claims priority to U.S. Provisional PatentApplication No. 62/316,722, entitled “System and Method for SterilizingMedical Devices,” filed on Apr. 1, 2016, the disclosure of which isincorporated by reference herein.

This application also claims priority to U.S. Provisional PatentApplication No. 62/376,517, entitled “Apparatus and Method to LinkMedical Device Sterilization Equipment,” filed on Aug. 18, 2016, thedisclosure of which is incorporated by reference herein.

BACKGROUND

Re-usable medical devices such as certain surgical instruments,endoscopes, etc., may be sterilized before re-use in order to minimizethe likelihood that a contaminated device might be used on a patient,which could cause an infection in the patient. Various sterilizationtechniques may be employed, such as steam, hydrogen peroxide, and vaporphase sterilization, either with or without a gas plasma and ethyleneoxide (EtO). Each of these methods may depend to a certain extent on thediffusion rates of the sterilization fluids (e.g., gases) upon themedical devices to be sterilized.

Before sterilization, medical devices may be packaged within containersor pouches having a semi-permeable barrier that allows transmission ofthe sterilizing fluid— sometimes referred to as a sterilant—but preventsadmission of contaminating organisms, particularly post-sterilizationand until the package is opened by medical personnel. For thesterilization cycle to be efficacious, the contaminating organismswithin the package must be killed because any organisms that survive thesterilization cycle could multiply and re-contaminate the medicaldevice.

Although the packaging may help prevent contamination of a sterilemedical device, the packaging may increase the difficulty of achieving asuccessful sterilization cycle because the packaging may impede thesterilant from reaching the medical device contained therein. This maybe particularly problematic for medical devices that havediffusion-restricted spaces therein because these diffusion-restrictedspaces may reduce the likelihood that a sterilization cycle may beeffective. For example, some endoscopes have a long narrow lumen intowhich the sterilant must diffuse in sufficient concentration forsufficient time to achieve a successful sterilization cycle.

Sterilization of medical devices may be performed with an automatedsterilization system such as a STERRAD® System by Advanced SterilizationProducts of Irvine, California. Examples of automated sterilizationsystems are described in U.S. Pat. No. 6,939,519, entitled “Power Systemfor Sterilization Systems Employing Low Frequency Plasma,” issued Sep.6, 2005, the disclosure of which is incorporated by reference herein;U.S. Pat. No. 6,852,279, entitled “Sterilization withTemperature-Controlled Diffusion Path,” issued Feb. 8, 2005, thedisclosure of which is incorporated by reference herein; U.S. Pat. No.6,852,277, entitled “Sterilization System Employing a Switching ModuleAdapter to Pulsate the Low Frequency Power Applied to a Plasma,” issuedFeb. 8, 2005, the disclosure of which is incorporated by referenceherein; and U.S. Pat. No. 6,447,719, entitled “Power System forSterilization Systems Employing Low Frequency Plasma,” issued Sep. 10,2002, the disclosure of which is incorporated by reference herein.Medical devices must be carefully arranged and controlled within thesterilization system to maintain an environment that allows foreffective sterilization. Each different medical device may require adifferent arrangement and sterilization process, meaning that use of asterilization system can still be error prone and may heavily rely uponoperator training and knowledge, or related documentation.

In addition, re-use of the same sterilizing chamber of a sterilizationsystem may result in cross contamination, particularly when thesterilization system is not operated correctly. Operator error mayresult in medical devices that are erroneously believed to bedecontaminated being returned to service. Confirming that asterilization cycle has been efficacious may help medical personnelavoid using a contaminated medical device on a patient. The sterilizedmedical device might not itself be checked for contaminating organismsbecause such an activity may introduce other contaminating organisms tothe medical device, thereby re-contaminating it. Thus, an indirect checkmay be performed using a sterilization indicator. A sterilizationindicator is a device that may be placed alongside or in proximity to amedical device being subject to a sterilization cycle, such that thesterilization indicator is subject to the same sterilization cycle asthe medical device. For instance, a biological indictor having apredetermined quantity of microorganisms may be placed into asterilization chamber alongside a medical device and subject to asterilization cycle. After the cycle is complete, the microorganisms inthe biological indicator may be cultured to determine whether any of themicroorganisms survived the cycle.

In view of the foregoing, it may be desirable to provide a sterilizationsystem that minimizes opportunities for operator error, therebymaximizing the likelihood of successful sterilization cycles, therebyminimizing the risk of patient infection. While a variety of systems andmethods have been made and used for surgical instrument sterilization,it is believed that no one prior to the inventor(s) has made or used thetechnology as described herein.

BRIEF DESCRIPTION OF THE DRAWINGS

It is believed the present invention will be better understood from thefollowing description of certain examples taken in conjunction with theaccompanying drawings, in which like reference numerals identify thesame elements and in which:

FIG. 1 depicts a schematic view of an exemplary sterilization system;

FIG. 2 depicts a high level flowchart of an exemplary set of steps thata sterilizing cabinet of the system of FIG. 1 could perform to sterilizea medical device;

FIG. 3 depicts a flowchart of an exemplary set of steps that thesterilizing cabinet of the system of FIG. 1 could perform to determine asterilization cycle and associated configuration;

FIG. 4 depicts a flowchart of an exemplary set of steps that thesterilizing cabinet of the system of FIG. 1 could perform to preparemedical devices for a sterilization cycle;

FIG. 5 depicts a flowchart of an exemplary set of steps that thesterilizing cabinet of the system of FIG. 1 could perform to completeand report results for a sterilization cycle;

FIG. 6 depicts a screenshot of an exemplary user interface that could bepresented via the sterilizing cabinet of the system of FIG. 1 , toselect a sterilization cycle;

FIG. 7 depicts a screenshot of an exemplary user interface that could bepresented via the sterilizing cabinet of the system of FIG. 1 , toprovide information to a user for configuring a “standard” sterilizationcycle;

FIG. 8 depicts a screenshot of an exemplary user interface that could bepresented via the sterilizing cabinet of the system of FIG. 1 , toprovide information to a user for configuring a “duo” sterilizationcycle;

FIG. 9 depicts a screenshot of an exemplary user interface that could bepresented via the sterilizing cabinet of the system of FIG. 1 , toprovide information to a user for configuring a “flex” sterilizationcycle;

FIG. 10 depicts a screenshot of an exemplary user interface that couldbe presented via the sterilizing cabinet of the system of FIG. 1 , toprovide information to a user for configuring a “express” sterilizationcycle;

FIG. 11 depicts a screenshot of an exemplary user interface that couldbe presented via the sterilizing cabinet of the system of FIG. 1 , topresent a user with a soft requirement for selecting a biologicalindicator for use with a selected sterilization cycle;

FIG. 12 depicts a screenshot of an exemplary user interface that couldbe presented via the sterilizing cabinet of the system of FIG. 1 , toguide a user through placement and configuration of medical devices foran “express” sterilization cycle;

FIG. 13 depicts a screenshot of an exemplary user interface that couldbe presented via the sterilizing cabinet of the system of FIG. 1 , toguide a user through placement and configuration of medical devices fora “flex” sterilization cycle;

FIG. 14 depicts a screenshot of an exemplary user interface that couldbe presented via the sterilizing cabinet of the system of FIG. 1 , toguide a user through placement and configuration of medical devices fora “duo” sterilization cycle;

FIG. 15 depicts a screenshot of an exemplary user interface that couldbe presented via the sterilizing cabinet of the system of FIG. 1 , toguide a user through placement and configuration of medical devices fora “standard” sterilization cycle;

FIG. 16 depicts a screenshot of an exemplary user interface that couldbe presented via the sterilizing cabinet of the system of FIG. 1 , todeliver results to a user for a completed sterilization cycle;

FIG. 17 depicts a screenshot of an exemplary user interface that couldbe presented via the sterilizing cabinet of the system of FIG. 1 , toidentify cycles associated with a positive biological indicator resultas communicated from an indicator analyzer of the system of FIG. 1 via acommunication hub of the system of FIG. 1 ;

FIG. 18 depicts a schematic view of an exemplary sterilizing cabinetthat may be used with the system of FIG. 1 ;

FIG. 19 depicts a schematic view of an exemplary biological indicatorassembly that may be used with the system of FIG. 1 ;

FIG. 20 depicts a schematic view of an exemplary indicator analyzer thatmay be used to process the biological indicator assembly of FIG. 19 aspart of the system of FIG. 1 ;

FIG. 21 depicts a perspective view of an exemplary form that theindicator analyzer of FIG. 20 may take;

FIG. 22 depicts a flowchart of exemplary steps that may be performed bythe indicator analyzer of FIG. 20 in preparation for analysis of thebiological indicator assembly of FIG. 19 ;

FIG. 23 depicts a flowchart of exemplary steps that may be performed bythe indicator analyzer of FIG. 20 based on whether the biologicalindicator assembly of FIG. 19 passes or fails analysis;

FIG. 24 depicts a high level flowchart of exemplary steps that may beperformed by the indicator analyzer of FIG. 20 to provide results for abiological indicator;

FIG. 25 depicts a flowchart of exemplary steps that may be performed bythe indicator analyzer of FIG. 20 to enforce control indicator usageprior to normal testing;

FIG. 26 depicts a flowchart of exemplary steps that may be performed bythe indicator analyzer of FIG. 20 to incubate and analyze a testindicator;

FIG. 27 depicts a flowchart of exemplary steps that may be performed bythe indicator analyzer of FIG. 20 to finalize and display the results ofan analysis;

FIG. 28 depicts a screenshot of an exemplary user interface that couldbe presented via a display of the indicator analyzer of FIG. 20 to allowa user to select a well for analysis;

FIG. 29 depicts a screenshot of an exemplary user interface that couldbe presented via a display of the indicator analyzer of FIG. 20 to guidea user during barcode scanning of an indicator;

FIG. 30 depicts a screenshot of an exemplary user interface that couldbe presented via a display of the indicator analyzer of FIG. 20 toindicate to a user that one or more incubation and analysis are beingperformed;

FIG. 31 depicts a screenshot of an exemplary user interface that couldbe presented via a display of the indicator analyzer of FIG. 20 to guidea user through activating an indicator;

FIG. 32 depicts a screenshot of an exemplary user interface that couldbe presented via a display of the indicator analyzer of FIG. 20 toprovide a detailed status of an indicator during incubation andanalysis;

FIG. 33 depicts a graph showing a plot of relative fluorescence unitsover time for several biological indicators having active enzymecontained therein as detected by the indicator analyzer of FIG. 20 ;

FIG. 34 depicts a graph showing a plot of relative fluorescence unitsover time for several biological indicators having inactive enzymecontained therein as detected by the indicator analyzer of FIG. 20 ;

FIG. 35 depicts a graph showing a plot of the change in slope of therelative fluorescence units for the biological indicators of FIGS. 33and 34 ;

FIG. 36 depicts a graph showing a plot of relative fluorescence unitsover time, along with an associated formula that may be executed by theindicator analyzer of FIG. 20 , associated with determining whether anactive enzyme is present according to a first exemplary method;

FIG. 37 depicts a graph showing a plot of relative fluorescence unitsover time, along with an associated formula that may be executed by theindicator analyzer of FIG. 20 , associated with determining whether anactive enzyme is present according to a second exemplary method;

FIG. 38 depicts a flowchart of exemplary steps that may be performed bya communication hub of the system of FIG. 1 ;

FIG. 39 depicts a schematic view of an exemplary communication hub thatmay be used to provide monitoring of and communications with one or moreother devices within the system of FIG. 1 via a user device;

FIG. 40 depicts a schematic view of an exemplary alternativecommunication hub that may be used to provide monitoring of andcommunications with one or more other devices;

FIG. 41 shows an exemplary set of steps that may be performed using acommunication hub, such as that shown in FIG. 39 or that shown in FIG.40 , to manage connections between the communication hub and one or moremedical device processing components;

FIG. 42 shows an exemplary set of steps that may be performed using acommunication hub, such as that shown in FIG. 39 or that shown in FIG.40 , to manage one or more medical device processing components;

FIG. 43 shows an exemplary set of steps that may be performed using acommunication hub, such as that shown in FIG. 39 or that shown in FIG.40 , to manage configurations of a network of medical device processingcomponents;

FIG. 44 shows an exemplary set of steps that may be performed using acommunication hub, such as that shown in FIG. 39 or that shown in FIG.40 , to manage communications within a network of medical deviceprocessing components;

FIG. 45 shows an example of an interface that may be used to select amedical device processing component via a user device coupled with thecommunication hub of FIG. 39 or directly via the communication hub ofFIG. 40 ;

FIG. 46 shows an example of an interface that may be used to viewinformation about a medical device processing component and its tasksvia a user device coupled with the communication hub of FIG. 39 ordirectly via the communication hub of FIG. 40 ;

FIG. 47 shows an example of an interface that may be used to viewadditional information on a medical device processing component's tasksvia a user device coupled with the communication hub of FIG. 39 ordirectly via the communication hub of FIG. 40 ;

FIG. 48 shows an example of an interface that may be used to viewadditional information on a medical device processing component's tasksvia a user device coupled with the communication hub of FIG. 39 ordirectly via the communication hub of FIG. 40 ;

FIG. 49 shows an example of an interface that may be used to select toview information from a medical device processing component in one ormore forms via a user device coupled with the communication hub of FIG.39 or directly via the communication hub of FIG.

FIG. 50 shows an example of an interface that may be used to viewinformation from a medical device processing component in a graphicalform via a user device coupled with the communication hub of FIG. 39 ordirectly via the communication hub of FIG. 40 ;

FIG. 51 shows an example of an interface that may be used to viewinformation from a medical device processing component in an alternategraphical form via a user device coupled with the communication hub ofFIG. 39 or directly via the communication hub of FIG. 40 ;

FIG. 52 shows an example of an interface that may be used to view failedtask information from a medical device processing component in agraphical form via a user device coupled with the communication hub ofFIG. 39 or directly via the communication hub of FIG. 40 ;

FIG. 53 shows an example of an interface that may be used to viewinformation from a medical device processing component in yet anotheralternate graphical form via a user device coupled with thecommunication hub of FIG. 39 or directly via the communication hub ofFIG. 40 ;

FIG. 54 shows an example of an interface that may be used to viewinformation from a medical device processing component in yet anotheralternate graphical form via a user device coupled with thecommunication hub of FIG. 39 or directly via the communication hub ofFIG. 40 ;

FIG. 55 shows an example of an interface that may be used to select toview information from a medical device processing component in one ormore graphical views via a user device coupled with the communicationhub of FIG. 39 or directly via the communication hub of FIG. 40 ;

FIG. 56 shows an example of an interface that may be used to view andmanage an indicator analyzer's tasks and information via a user devicecoupled with the communication hub of FIG. 39 or directly via thecommunication hub of FIG. 40 ;

FIG. 57 shows an example of an interface that may be used to view andmanage additional information on an indicator analyzer task via a userdevice coupled with the communication hub of FIG. 39 or directly via thecommunication hub of FIG. 40 ;

FIG. 58 shows an example of an interface that may be used to view andmanage additional information for a medical device processing componentconnected to a network via a user device coupled with the communicationhub of FIG. 39 or directly via the communication hub of FIG. 40 ;

FIG. 59 shows an example of an interface that may be used to provideguidance to a user while adding a medical device processing component toa network via a user device coupled with the communication hub of FIG.39 or directly via the communication hub of FIG. 40 ; and

FIG. 60 shows an example of an interface that may be used to provideguidance to a user while adding a medical device processing component toa network via a user device coupled with the communication hub of FIG.39 or directly via the communication hub of FIG. 40 .

DETAILED DESCRIPTION

The following description of certain examples of the technology shouldnot be used to limit its scope. Other examples, features, aspects,embodiments, and advantages of the technology will become apparent tothose skilled in the art from the following description, which is by wayof illustration, one of the best modes contemplated for carrying out thetechnology. As will be realized, the technology described herein iscapable of other different and obvious aspects, all without departingfrom the technology. Accordingly, the drawings and descriptions shouldbe regarded as illustrative in nature and not restrictive.

It is further understood that any one or more of the teachings,expressions, embodiments, examples, etc. described herein may becombined with any one or more of the other teachings, expressions,embodiments, examples, etc. that are described herein. Thefollowing-described teachings, expressions, embodiments, examples, etc.should therefore not be viewed in isolation relative to each other.Various suitable ways in which the teachings herein may be combined willbe readily apparent to those of ordinary skill in the art in view of theteachings herein. Such modifications and variations are intended to beincluded within the scope of the claims.

I. Overview of Exemplary Sterilization System and Devices

FIG. 1 depicts a schematic view of an exemplary system (10) ofinterconnected devices that may be configured to perform methods forsterilizing medical devices. System (10) of this example includes asterilizing cabinet (100), a biological indicator analyzer (102), amedical device reprocessor (104), a communication hub (20), a server(106), and a user device (108). As will be described in greater detailbelow, sterilizing cabinet (100) may have a sealable sterilizationchamber where contaminated medical devices may be placed. A user mayinteract with sterilizing cabinet (100) via a set of user inputs, suchas physical buttons, a keyboard, a touch pad or mouse, other controls,and/or a touch screen display interface. A display of sterilizingcabinet (100) may provide users with information, configuration options,status and duration of sterilization cycles and preparation, and othersimilar information.

Sterilizing cabinet (100) is in communication with a server (106), suchas a hospital record server or hospital local area network server.Server (106) may receive information from sterilizing cabinet (100)relating to sterilization procedures performed by the sterilizingcabinet (100), such as sterilization procedure durations and results;whether a particular sterilization procedure provided a subsequentindication of biological contamination; the identification of a user ortechnician who initiated, canceled, or complete a sterilizationprocedure; consumable materials or supplies used during a sterilizationprocedure; diagnostic information and systems errors; and/or otherinformation. Server (106) may also provide information to thesterilizing cabinet (100) such as software updates, configurationupdates, user authentication information, biological indicator useprotocols, and other information. Communication between sterilizingcabinet (100) and server (106) may be accomplished via any suitablewired and/or wireless communication technology, such as Ethernet, Wi-Fi,Bluetooth, USB, infrared, NFC, and/or other technologies.

In system (10) of the present example, sterilizing cabinet (100) is alsoin communication with a communication hub (20), which itself is incommunication with one or more biological indicator analyzers (102). Aswill be described in greater detail below, biological indicator analyzer(102) may comprise a desktop or wall mounted device that receives abiological indicator and measures one or more characteristics of thebiological indicator in order to gather data that may be used todetermine whether the biological indicator tests positive, indicatingthat contamination is present after a sterilization procedure; ornegative, indicating that no contamination is present after thesterilization procedure.

In some versions, biological indicator analyzer (102) will measure andtransmit data to communication hub (20), which will process the data todetermine if there is contamination. In other versions, biologicalindicator analyzer (102) itself may both measure and analyze the data todetermine whether there is contamination, and communication hub (20) maybe used to receive, gather, and transmit such information to sterilizingcabinet (100) and/or other devices as will be described in greaterdetail below. In still other versions, biological indicator analyzer(102) and communication hub (20) may be different components of a singledevice; or may be components of sterilizing cabinet (100). Suchvariations may be desirable depending upon a particular implementationenvironment and user needs, such that a single device incorporatingsterilizing cabinet (100), communication hub (20), and/or biologicalindicator analyzer (102) may be desirable in a semi-portable unit; whilean implementation supporting a one-to-many relationship betweensterilizing cabinet (100) and biological indicator analyzer (102) may bemore advantageous for permanent installation in a large hospital withmany users.

As will be described in greater detail below and as alluded to above,communication hub (20) is configured to process and relay informationfrom biological indicator analyzer (102) to sterilizing cabinet (100).Biological indicator analyzer (102) and sterilizing cabinet (100) mayeach be coupled with communication hub (20) via any suitable wiredand/or wireless communication technology, such as Ethernet, Wi-Fi,Bluetooth, USB, infrared, NFC, and/or other technologies. It should alsobe understood that communication hub (20) may be in communication withvarious other components, via wire or wirelessly, including but notlimited to various user devices (108) such as desktop computers, laptopcomputers, mobile computing devices, smartphones, etc. Moreover,communication hub (20) may be in communication with server (106) viawire or wirelessly.

In versions where communication hub (20) is in communication with server(106), communication hub (20) may relay data, etc., between sterilizingcabinet (100) and server (106), such that communication hub (20) servesas an intermediary between sterilizing cabinet (100) and server (106).It should therefore be understood that, in some versions, sterilizingcabinet (100) may be in communication with server (106) viacommunication hub (20) instead of being directly in communication withserver (106). Similarly, communication hub (20) may serve as anintermediary between sterilizing cabinet (100) and biological indicatoranalyzer (102); between sterilizing cabinet (100) and user device (108);between biological indicator analyzer (102) and server (106); betweenbiological indicator analyzer (102) and user device (108); betweenreprocessor (104) and server (106); between reprocessor (104) and userdevice (108); and/or between user device (108) and server (106). Varioussuitable components and configurations that may be used to formcommunication hub (20) will be apparent to those of ordinary skill inthe art in view of the teachings herein.

II. Exemplary Sterilization Processes and Interfaces

A. Overview of Sterilization Process

FIG. 2 depicts a high level flowchart of an exemplary set of steps thatsystem (10) could perform to sterilize a medical device. A user mayinteract with the system via a user interface such as a keyboard ortouch screen of sterilizing cabinet (100), as will be described ingreater detail below; or via an input device in communication withsterilizing cabinet (100). Initially, sterilizing cabinet (100) maydisplay one or more sterilization cycles via a display and then receivea sterilization cycle selection (block 200) from the user. Sterilizingcabinet (100) may be configured to perform one or more sterilizationcycles, with different sterilization cycles being appropriate fordifferent types and quantities of medical devices.

Sterilizing cabinet (100) may also display instructions indicatingwhether a biological indicator should be used with the selectedsterilization cycle, and receive a biological indicator identification(block 202). A biological indicator may be placed inside a sterilizationchamber of sterilizing cabinet (100) before the sterilization cyclebegins and may remain in the sterilization chamber during asterilization cycle. The user may thus identify the particularbiological indicator (block 202) before the biological indicator isplaced in the sterilization chamber. The biological indicator maycontain microorganisms that are responsive to a particular sterilizationcycle. Upon completion of the sterilization cycle, the biologicalindicator may be tested for the microorganisms in order to provide ameasure of the effectiveness of the sterilization cycle. A biologicalindicator may not necessarily be required for all sterilization cycles,but may be required based on hospital rules or local regulations. Whenused, a biological indicator may be identified by manual input, such askeyboard entry of a biological indicator type or identifier; or may beidentified automatically, such as by an optical scan of an opticalidentifier or a wireless scan of an RFID or other unique identifier.

Selection of a sterilization cycle (block 200) and identification of abiological indicator (block 202) may define one or more requirements forthe configuration and arrangement of medical devices within sterilizingcabinet (100). A door of the sterilization chamber of sterilizingcabinet (100) may be opened and instructions may be displayed to guide auser through preparation of the sterilization cycle (block 204),including placement of the biological indicator, placement of medicaldevices, closing the door of the sterilization chamber of thesterilization cabinet (100), and/or other changes in preparation. Beforeinitiating the actual sterilization cycle (block 208), sterilizationcabinet (100) may also perform load conditioning (block 206) of themedical devices that are loaded in the sterilization chamber of thesterilization cabinet (100). Such load conditioning (block 206) mayinclude verifying that the sterilization chamber is sealed; verifyingcontents of the sterilization chamber; checking physical characteristicsof the contents of the sterilization chamber such as moisture levels,content volume, content weight, internal temperature, or othercharacteristics; and/or performing one or more conditioning steps thatmay include heat treatment, chemical treatment, plasma treatment, orother types of treatment to reduce moisture, raise temperature, and/orotherwise prepare the medical devices in the sterilization chamber forthe sterilization cycle.

Once the load conditioning (block 206) has been completed, the selectedsterilization cycle itself may be performed (block 208). Thesterilization cycle (block 208) may include exposing the medicaldevice(s) in the sterilizing chamber to pressurized sterilant gas,further heat treatment, chemical treatment, plasma treatment, vacuumtreatment, and/or other types of sterilization procedures. After thesterilization cycle (block 208) is completed, the complete sterilizationresults may be displayed to a user via a display of the sterilizationcabinet; transmitted to server (106); printed locally; and/or displayed,transmitted, and/or stored via other devices as may be desirable.

Sterilization cabinet (100) may also provide results (block 210) of thesterilization cycle. This provision of results (block 210) may includeresults from analysis of a biological indicator via biological indicatoranalyzer (102) as described below. These results may include a positiveor negative indication of contamination present in the biologicalindicator at the completion of the sterilization cycle (block 208). Incases where the biological indicator suggests that contamination ispresent after completion of the sterilization cycle (block 208),additional actions may be taken such as alerting a user of the positivetest and analysis of sterilization cycle history in order to determineif other past cycles may be the cause of the contamination; and/or ifsubsequently sterilized medical devices may need to be re-sterilized.

B. Exemplary Sterilization Cycle Selection and Biological IndicatorIdentification

FIG. 3 shows an exemplary set of steps that sterilizing cabinet (100)could perform to receive a sterilization cycle selection (block 200) andreceive a biological indicator identification (block 202). In otherwords, the method shown in FIG. 3 may be viewed as showing severalsub-steps that may be performed as part of the sterilization cycleselection step (block 200) and the biological indicator identificationstep (block 202) of FIG. 2 .

When a user initially interacts with sterilizing cabinet (100), afterlogging in or otherwise authenticating their use of the sterilizingcabinet (100), sterilizing cabinet (100) may display a sterilizationcycle selection (block 300) to the user via a graphical user interfacesuch as the one shown in FIG. 6 . As shown in FIG. 6 , a sterilizationcycle selection button (600) is a touch screen element that shows thesterilization cycle type, such as “standard,” “duo,” “flex,” and“express;” and may show additional information such as sterilizationcycle duration, a type of biological indicator associated with asterilization cycle, and other information, for each sterilization cycleselection, as well as instructions for either selecting a cycle orscanning a biological indicator (601). The sterilization cycle selectionscreen of FIG. 6 also includes a sterilization cycle information button(602) for each sterilization cycle selection, which may be selected by auser to display additional information that may help a user make asterilization cycle choice. It should be understood that the “standard,”“duo,” “flex,” and “express” sterilization cycles of the present exampleare merely illustrative. Sterilization cabinet (100) may alternativelyoffer any other suitable number and types of sterilization cycles forselection.

While FIG. 6 shows each sterilization cycle being associated with aspecific type of biological indicator, such as Biological IndicatorApollo Type A, or Biological Indicator Apollo Type B, differentembodiments may support different configurations of biological indicatortype. In some embodiments, each sterilization cycle may have a differenttype of biological indicator, such that there may be four or moredifferent types of biological indicator each with a specificapplication. However, in other embodiments, a single biologicalindicator may be adapted for use with any sterilization cycle, such thatonly one type of biological indicator is needed. The number and type ofbiological indicator required for different sterilization cycle may varydepending upon the desired cost, shelf life, market of sale, or otherfactors. While the embodiment shown in FIGS. 6 through 17 requires aType A and Type B indicator, the technology and interfaces shown couldbe modified to support as few as one type of biological indicator, or asmany of a plurality of biological indicator as may be needed.

FIGS. 7-10 show examples of sterilization cycle information screens thatmay be displayed after interaction with a sterilization cycleinformation button (602). FIG. 7 shows an exemplary cycle informationscreen for a “standard” sterilization cycle, which includes asterilization cycle description (608); a sterilization cycle durationestimate (614); a listing of medical devices (610) suitable for thatparticular sterilization cycle; and a biological indicator visual aid(612) identifying the type, color, and barcode or identifier locationfor a biological indicator that is compatible with that particularsterilization cycle. In this particular example, the sterilization cycledescription (608) indicates that the “standard” sterilization cycle hasa cycle time of approximately 47 minutes; and is intended forinstruments including single channel stainless steel lumens and generalmedical instruments. The listing of medical devices (610) includes theexamples of arthroscope and laparascopic instrument sets, eyeinstruments, cystoscope instruments, rigid and semi-rigid ureteroscopes,cameras and light cords, rechargeable batteries, Doppler cords anddefibrillator paddles, orthopedic drills and saws, and ultrasoundprobes/transducers. The biological indicator visual aid (612) shows thatthe biological indicator for the “standard” sterilization cycle is a“Type A” biological indicator with a teal cap, though it should beunderstood that other types, colors, and configurations may also beshown.

FIGS. 8-10 show similar information for a “duo” sterilization cycle(616), “flex” sterilization cycle (618), and “express” sterilizationcycle (620). In particular, in FIG. 8 , the sterilization cycledescription (616) indicates that the “duo” sterilization cycle has acycle time of approximately 60 minutes; and is intended for instrumentsincluding single channel flexible endoscopes, flexible endoscopeswithout lumens, cameras, and accessory light cords. The listing ofmedical devices for the “duo” sterilization cycle includes the examplesof bronchoscopes, hysteroscopes, cystoscopes, flexible ureteroscopes,choledochoscopes, thoracoscopes, intubation fiberscopes, light cords,and cameras. The biological indicator visual aid for the “duo”sterilization cycle shows that the biological indicator for the “duo”sterilization cycle is a “Type A” biological indicator with a teal cap,though it should be understood that other types, colors, andconfigurations may also be shown.

In FIG. 9 , the sterilization cycle description (618) indicates that the“flex” sterilization cycle has a cycle time of approximately 42 minutes;and is intended for instruments including single channel flexibleendoscopes and flexible endoscopes without lumens. The listing ofmedical devices for the “flex” sterilization cycle includes the examplesof bronchoscopes, hysteroscopes, cystoscopes, flexible ureteroscopes,choledochoscopes, thoracoscopes, and intubation fiberscopes. Thebiological indicator visual aid for the “flex” sterilization cycle showsthat the biological indicator for the “flex” sterilization cycle is a“Type A” biological indicator with a teal cap, though it should beunderstood that other types, colors, and configurations may also beshown.

In FIG. 10 , the sterilization cycle description (620) indicates thatthe “express” sterilization cycle has a cycle time of approximately 24minutes; and is intended for general medical devices requiring surfacesterilization, sterilization of mated stainless steel, and titaniumsurfaces. The listing of medical devices for the “express” sterilizationcycle includes the examples of da Vinci endoscopes, rigid or semi-rigidendoscopes without lumens, general surgery devices without lumens,rechargeable batteries, eye instruments without lumens, and ultrasoundprobes/transducers. The biological indicator visual aid for the“express” sterilization cycle shows that the biological indicator forthe “flex” sterilization cycle is a “Type B” biological indicator with adark gray, though it should be understood that other types, colors, andconfigurations may also be shown.

Sterilization cycle information screens such as those illustrated inFIGS. 7-10 may show additional information, such as pictures and imagesof medical devices that may be sterilized by the sterilization cycle,sterilization methods used during the sterilization cycle, maximum heator pressure reached within the sterilization chamber during thesterilization cycle, the number of times the sterilization cycle hasbeen run during a period of time, the last time the sterilization cyclewas run, and/or any other information that a user may find useful.

Referring to FIGS. 3 and 6 together, the sterilization cycle selectionscreen of FIG. 6 may additionally instruct a user to manually select(block 304) a sterilization cycle and/or select and scan a biologicalindicator (block 302). If a user chooses to scan a biological indicator(block 302) (e.g., using an optical or wireless scanner to scan abarcode, QR code, optical identifier, RFID, or other wireless identifierof a biological indicator), the display may be updated to instead show afiltered selection (block 306) of sterilization cycles that may beselected because they are compatible with the selected and scannedbiological indicator (block 302). In some implementations, interface maybe shown with sterilization cycle selections that have been filtered(block 306) based upon a scanned or selected biological indicator (block302). One example is a screen that has a sterilization cycle associatedwith a “type B” biological indicator grayed out and being renderedun-selectable. This particular screen is presented in response to a“type A” biological indicator being selected or scanned (block 304),such that the screen only enables selection of filtered sterilizationcycles that are particularly associated with the “type A” biologicalindicator. Another example is a screen that has the sterilization cyclesassociated with a “type A” biological indicator grayed out and beingrendered un-selectable. This particular screen is presented in responseto a “type B” biological indicator being selected or scanned (block304), such that the screen only enables selection of the filteredsterilization cycle that is particularly associated with the “type B”biological indicator. However, in embodiments that support or requireonly one type of biological indicator, the process of filtering bysupported sterilization cycle type after selecting a biologicalindicator would not be required.

Referring back to FIGS. 3 and 6 together, a user may not always scan abiological indicator (block 302) before making a sterilization cycleselection. The user may instead make a manual selection (block 304) fromany of the displayed sterilization cycle selection buttons (600). Aftermaking a manual selection (block 304) of a sterilization cycle, if theuser also scanned or selected a biological indicator (block 308) earlierin the process, then the biological indicator may be verified (block324) for the selected sterilization cycle. Verification (block 324) mayinclude verifying compatibility with system (10) generally,compatibility with the sterilization cycle selected, verifying that thebiological indicator is not expired, and/or other verifications.

A number of exemplary interfaces may be used to indicate to a user thatthere is a warning or error related to the biological indicator basedupon the verification (block 324). A warning message may be displayedwhen the biological indicator is from a third party manufacturer wherethe compatibility of the biological indicator with sterilizing cabinet(100), biological indicator analyzer (102), and/or other devices ofsystem (10) has not been verified or validated. The warning message mayinclude buttons to cancel the use of the biological indicator to givethe user a chance to replace the biological indicator with a verifiedbiological indicator (block 326); or bypass the warning and continue tocomplete the sterilization cycle and indicator selection (block 328).

A warning message may be displayed when the identified biologicalindicator is incompatible with the selected sterilization cycle, such aswhen a “type A” biological indicator is selected and an “express”sterilization cycle is selected. The warning message may be accompaniedby buttons that allow a user to cancel the biological indicator andsterilization cycle selections entirely; or to replace the mismatchedbiological indicator with a new biological indicator that is compatiblewith the selected sterilization cycle (block 326). Other warning messagemay be displayed to indicate to a user that the selected “type B”biological indicator is not valid for use with the selected “standard,”“flex,” or “duo” sterilization cycle. Again, this warning message may beaccompanied by buttons allowing the user to cancel the biologicalindicator and sterilization cycle selections entirely; or to replace themismatched biological indicator with a new biological indicator that iscompatible with the selected sterilization cycle (block 326). However,in embodiments where only a single type of biological indicator issupported or required, the warning messages described above would not berequired to indicate a mismatch between a selected cycle and a selectedbiological indicator.

Some exemplary interfaces may be displayed when a user selects or scansa biological indicator that is unidentifiable or entirely incompatiblewith sterilizing cabinet (100), biological indicator analyzer (102),and/or other devices. These warning messages indicate to the user thatthe currently selected biological indicator is known to be incompatibleand must be replaced with a compatible biological indicator beforecontinuing. These messages may be displayed along with buttons allowinga user to cancel the biological indicator and sterilization cycleselections entirely; or to replace the current biological indicator witha new biological indicator that is compatible with the selectedsterilization cycle (block 326).

Other exemplary interfaces may be displayed when a user selects or scansa biological indicator that is expired or has been discontinued orrecalled. These messages may be accompanied by buttons allowing a userto cancel the biological indicator and sterilization cycle selectionsentirely; or to replace the expired/discontinued/recalled biologicalindicator with a new biological indicator (block 326). However, inembodiments where only a single type of biological indicator issupported or required, the warning messages of described above could beconsolidated to only require a single biological indicator type.

If, after any of the above described warning and error messages, a userselects to continue or bypass the warning, sterilization cabinet (10)will count the biological indicator as having been verified (block 324)despite the warning; and the sterilization cycle selection andbiological indicator identification will be complete (block 328). If,after a warning or error, a user chooses to replace (block 326) thepreviously selected biological indicator with another biologicalindicator, that newly selected biological indicator may be verified(block 324). If there are no warnings or errors based on the newlyselected biological indicator, the sterilization cycle selection andbiological indicator identification is complete (block 328).

If no biological indicator is scanned (block 308) prior to a manualselection (block 304) of a sterilization cycle, sterilization cabinet(100) will determine if there is a hard requirement (block 310) or softrequirement (block 314) for using a biological indicator. Determinationof whether there is a hard requirement (block 310) or soft requirement(block 314) may depend upon a variety of configurable factors that mayvary depending upon a particular hospital where system (10) is used, aparticular geographical region in which system (10) is used, a user'sinsurance carrier requirements, and/or various other factors.

For example, in some versions there may be a hard requirement (block310) that requires that a biological indicator be used in certaincircumstances in order to comply with a rule, law, or other regulation.If such a hard requirement applies to the current sterilization cyclethat is being configured (block 310), the hard indicator requirementsmay be displayed (block 312) since a user has not yet scanned orselected a biological indicator (308). Other exemplary interfaces may bedisplayed when a hard requirement applies (block 310) to the selectedsterilization cycle. An exemplary interface may have a hard requirementdescription that indicates to the user the circumstances of theparticular hard requirement that applies (block 310); and a biologicalindicator guide shows a graphical representation of the biologicalindicator that is required to continue. Such an interface may beaccompanied by a button that allows a user to cancel the selectionprocess entirely. However, the interface may not have a button thatwould allow the user to bypass the requirement or continue in theabsence of an appropriate biological indicator.

Another interface may be similar to that described above, but whichrequires a “type B” biological indicator in order to continue theprocess. The hard requirement warning screens described above may showadditional information, such as a contact number or information forindividuals that can provide support, such as technical supportpersonnel for sterilizing cabinet (100), the biological indicator, thehospital where sterilizing cabinet (100) is located, and/or otherindividuals that might be able to provide assistance when a userunexpectedly receives a hard requirement (block 310). However, inembodiments that only support or require a single biological indicatortype, only a single interface requiring a single biological indicatormay be implemented.

While the particular hard requirement description discussed previouslymay be a “once per 24 hours” requirement, other requirements may exist.For example, in some versions there may be a hard requirement to use abiological indicator for every cycle, every other cycle, every X numberof cycles, a certain number of times per day, a certain number of timesper period of hours, and/or other scenarios as may be configured.

While a hard requirement is intentionally designed to appear as beingimpassable without the selection of an appropriate biological indicator,some versions of system (10) may also be configured to display a set ofhard requirement bypass screens to allow users to bypass (block 320)even a hard requirement in case of emergency or other substantial need.An exemplary interface may be configured to receive a pass code,supplied by support personnel or hospital administrators that will allowthe hard requirement to be bypassed. An exemplary interface may bedisplayed to indicate to a user that the pass code was accepted, and maydisable hard requirements during sterilization cycle configuration for acertain number of sterilization cycles; or for a certain period of time.

Referring back to FIG. 3 , if the hard bypass is successful (block 320),the sterilization cycle selection and biological indicatoridentification is complete (block 328). Bypassing a hard requirement mayresult in additional alerts or notifications being sent to hospitaladministrators or other responsible individuals, and may transmitadditional information to server (106) indicating the particularcircumstances of the hard bypass (block 320) so that the event can beexamined at a later time. A code bypass is one example of a hardrequirement bypass (block 320), but other embodiments exist. Forexample, hard requirement bypass (block 320) may also be accomplished byscanning of an optical barcode, RFID tag, or other indicator that may beheld by a small group of individuals within a hospital; or scanning of adummy indicator that allows for a single bypass or limited number ofbypasses.

If there is no hard requirement (block 310), sterilization cabinet (100)will determine if there is a soft requirement (block 314). A softrequirement may conditionally apply in similar circumstances as the hardrequirement, such as for every sterilization cycle, intermittentsterilization cycles, intermittent time periods, or other scenarios. Ifa soft requirement exists (block 314), the soft biological indicatorrequirement may be displayed (block 316) via a screen such as that shownin FIG. 11 . FIG. 11 shows a soft requirement description (626), abiological indicator visual guide (622), and a soft bypass (624) button.The soft requirement description (626) indicates that it has been 24hours or more since the last biological indicator was processed, suchthat a new biological indicator should be scanned to continue. A usermay cancel the cycle, or may choose the soft bypass (624) button if theydo not wish to select a biological indicator. If the soft bypass isselected block (318), the sterilization cycle selection and indicatoridentification is complete (block 328). Additionally, if there is nohard requirement (block 310) and no soft requirement (block 314), theuser may proceed with no biological indicator and no need for bypass;and the sterilization cycle selection and biological indicatoridentification is complete (block 328).

If no biological indicator is scanned prior manual selection of thesterilization cycle (block 304), and a hard or soft requirement exists(block 310, block 314) and is not bypassed (block 318, block 320), theuser must scan a biological indicator (block 308) before sterilizationcabinet (100) will proceed. Once a biological indicator is scanned(block 308), biological indicator verification (block 324) will proceedas previously described. In the event that either a soft or hard bypassis used (block 318, block 320), an additional warning may be displayedto notify the user of the requirement for using a biological indicator.

C. Exemplary Medical Device Placement and Load Conditioning Process

FIG. 4 depicts an exemplary set of steps that sterilizing cabinet (100)could perform to guide a user through placement of medical devices inthe sterilizing chamber of sterilizing cabinet (100) and prepare themedical devices for a sterilization cycle. It should be understood thatthe method shown in FIG. 4 may be viewed as showing several sub-stepsthat may be performed as part of the sterilization cycle preparationstep (block 204) and the load conditioning step (block 206) of FIG. 2 .

Once the sterilization cycle has been selected (block 200) and thebiological indicator has been identified (block 202), sterilizingcabinet (100) may display (block 400) a medical device placement thatserves as a visual guide to a user's placement of medical devices withinthe sterilizing chamber of sterilizing cabinet (100), based on theselected sterilization cycle (block 200). FIGS. 12-15 show examples ofscreens that may be used to display (block 400) medical deviceplacement. FIG. 12 shows an interface having a cycle description (650)that may describe one or more characteristics of the medicalsterilization devices sterilized by the sterilization cycle, materialssterilized by the sterilization cycle, or processes used during thesterilization cycle. The interface may also have one or more placementinstructions (652) that provide the user with instructions on where toplace medical instruments that are to be sterilized (e.g., in relationto a shelf in the sterilization chamber), as well as where to place thebiological indicator (653), if applicable to the selected sterilizationcycle. The interface may also have a graphical indication (654) ofplacement of medical devices that may have a shape or appearance that isvisually similar to a sterilization chamber of sterilizing cabinet(100). FIG. 13 shows a similar interface that provides a visualplacement guide for a “flex” cycle (656), while FIG. 14 shows a similarinterface for a “duo” cycle (658), and FIG. 15 shows a similar interfacefor a “standard” cycle (660).

Referring back to FIG. 4 , once medical device placement is complete(block 402), the user may press a start button or other buttonindicating that medical device placement is complete and sterilizingcabinet (100) may verify medical device placement (block 404). Placementverification may occur in varying ways depending upon a particularembodiment. In some versions, placement verification may simply be afinal display and confirmation of the visual placement guide (654). Inother versions, placement verification may be by way of imaging devicesor photo sensors, weight sensors, two-dimensional or three-dimensionalcamera image capture and comparison, or similar types of sensors thatmay detect the physical presence of an object within a defined space byway of recognizing one or more physical characteristics of its presence.Placement verification (block 404) could also be accomplished by way ofa wireless RFID or NFC scanner and placement of an RFID or NFC chip onmedical devices, either at the time of manufacture, the time of use, orsterilization. One or more wireless scanners could be placed in walls ofsterilizing cabinet (100) and could be configured to, at the time ofverification (block 404), identify the locations of medical deviceswithin the sterilization chamber and verify that they are within aconfigured distance of the scanner. Versions having a wireless scannercould further be configured to identify placement of medical devices aswell as types of medical devices, which could be used as an additionalconfirmation that the proper sterilization cycle is selected for thetypes of medical devices placed in the sterilization chamber.

If medical device placement cannot be verified (block 404), the cycleplacement guide may be displayed again (block 400). If medical deviceplacement is verified (block 404), sterilizing cabinet (100) may start aload conditioning process (block 406). The load conditioning process(406) prepares the sterilization chamber and the medical devices withinthe sterilization chamber for optimal sterilization during asterilization cycle. Conditioning may include controlling and optimizingone or more characteristics of the sterilization chamber. For example,during load conditioning, sterilizing cabinet (100) may continuouslymonitor the level of moisture (block 408) within the sterilizationchamber while reducing the level of moisture by, for example,circulating and dehumidifying the air of the sterilization chamber,creating a vacuum within the sterilization chamber, heating thesterilization chamber, and/or other methods for dehumidifying a sealedchamber. This may continue until sterilizing cabinet (100) determinesthat an acceptable level of moisture has been reached (block 410).

Sterilizing cabinet (100) may also continuously detect the temperature(block 412) within the sterilization chamber while heating thesterilization chamber by, for example, convection of heated air,conduction through an interior surface of the sterilization chamber,and/or using other techniques. This may continue until sterilizingcabinet (100) determines that an acceptable internal temperature hasbeen reached (block 414). Various conditioning actions such ascontrolling temperature or humidity may be performed in parallel or insequence. While the one or more conditioning actions are beingperformed, sterilizing cabinet (100) may display an interface indicatingto a user the duration of time before the sterilization cycleperformance may begin. Once all load conditioning criteria have beensuccessfully met, load conditioning is complete (block 416) and thesterilization cycle may then be performed (block 208). It shouldtherefore be understood that sterilizing cabinet (100) is configuredsuch that the sterilization cycle (block 208) is not actually initiateduntil after the load conditioning process (block 206) is complete.

Load conditioning (block 206) may not always be possible, due to systemerror, abnormally high moisture levels, or abnormally low temperatures.An exemplary interface may be displayed when attempts to reduce moisturefail or other general errors occur during load conditioning. Theinterface provides additional guidance to a user so that furtherattempts to conditioning may be made. Another exemplary interface may bedisplayed when sterilization chamber temperatures are not able to beraised to an acceptable range; and indicates to a user the reason forthe failure.

As noted above, sterilization cabinet (100) may begin performing thesterilization cycle (block 208) automatically and immediately after loadconditioning (block 206) has been completed. During performance of thesterilization cycle (block 208), an interface may be displayed thatshows a duration remaining for cycle, an overall cycle completion, and acurrent cycle stage, which describes what part of the sterilizationcycle is currently being performed (e.g. plasma, vacuum, injection,heat, chemical treatment), in addition to buttons for canceling thesterilization cycle and viewing further information on the sterilizationcycle. It should be understood that a screen like the one describedabove may automatically replace other interfaces after load conditioning(block 206) has been completed.

D. Exemplary Reporting of Sterilization Cycle Results

FIG. 5 depicts an exemplary set of steps that sterilizing cabinet (100)could perform to complete and report results of a sterilization cycleupon completion of the cycle (block 208). In other words, the methodshown in FIG. 5 may be viewed as showing several sub-steps that may beperformed as part of the provision of results step (block 210) of FIG. 2. If the sterilization cycle was canceled or unable to complete due toerror or by a user action (block 500), sterilizing cabinet (100) mayremain sealed and may also display (block 502) an interface that shows asterilization cycle cancellation message as well as various detailsrelating to the sterilization cycle, such as date, time, configuration,elapsed time, sterilization cycle operator, the stage at which thesterilization cycle failed, and other information that may be used toidentify why the sterilization cycle failed. Such displayed informationand other information relating to the sterilization cycle may also besent (block 504) to the server (106) or to a printer, or both, forfurther use or analysis.

If the sterilization cycle completes (block 506), sterilization cabinet(100) may display a sterilization cycle complete (block 508) interfacesuch as that shown in FIG. 16 , which may include information such assterilization cycle identifier, sterilization cycle type, start time,duration, operator, and other information (666). If a biologicalindicator is not present (block 510) during the sterilization cycle, thedisplayed information and other information associated with thesterilization cycle may be sent (block 504) to the server (106) or to aprinter, or both, for further use or analysis. If a biological indicatorwas selected and used (block 510) during the sterilization cycle, thebiological indicator may be removed by the user and placed in biologicalindicator analyzer (102) to determine the efficacy of the sterilizationtreatment (block 512), as described in greater detail below. If dataprovided by biological indicator analyzer (102) indicates that thebiological indicator tests negative for contamination (block 514), theresults of the sterilization cycle as well as the results of theindicator analysis (block 512) are sent (block 504) to server (106) or aprinter, or both. If data provided by biological indicator analyzer(102) suggests that the biological indicator tests positive forcontamination (block 514), sterilization cabinet (100) may display thesterilization cycle history (block 516) for sterilization cyclesoccurring before the immediate sterilization cycle so that a user maydetermine if any prior performed sterilization cycles may need to bere-run to ensure the sterility of the medical devices involved. Ifsubsequent sterilization cycles were performed after the above-describedsterilization cycle and before the biological indicator analysis (block512) is complete, those subsequent sterilization cycles may also need tobe re-run.

FIG. 17 shows an example of an interface for displaying sterilizationcycle history of potentially affected sterilization cycles to a user inthe event of a positive biological indicator result (block 514). Theexample interface of FIG. 17 shows the biological indicator result(668); a biological indicator identifier (670), which relates a uniquebiological indicator to the sterilization cycle for which it wasselected or scanned, a time at which the biological indicator wasanalyzed (672); as well as a previous sterilization cycle window, whichshows a sequential listing of the previously performed sterilizationcycles (674) that may be affected, which goes back at least as far asthe previously performed sterilization cycle which included a biologicalindicator; a sterilization cycle completion time for each affectedsterilization cycle (676); a sterilization cycle type for each affectedsterilization cycle (678); and a biological indicator result for eachaffected sterilization cycle (680). The interface of FIG. 17 could beused by a user to identify a set of affected sterilization cycles, whichin some cases will be each sterilization cycle that was performed (i)prior to the sterilization cycle that generated a positive indication ofcontamination and (ii) subsequent to the most recent sterilization cyclethat generated a negative indication of contamination. This set ofaffected sterilization cycles provides a narrow listing of eachsterilization cycle that may not have been fully effective as a resultof a change in performance of sterilizing cabinet (100) or other erroror contamination that also may have caused the current positiveindication of contamination. Medical devices that were believed to besterilized during the affected sterilization cycles may be reexaminedand/or re-sterilized in order to ensure safe use.

III. Exemplary Sterilizing Cabinet

FIG. 18 depicts an exemplary set of components that may be incorporatedinto sterilizing cabinet (100) of system (10). In particular, FIG. 18shows an exemplary sterilizing cabinet (150) that is operable to performthe various methods described above and shown in FIGS. 2-5 . Sterilizingcabinet (150) of the present example includes a sterilization chamber(152), which is configured to receive one or more medical devices forsterilization. While not shown, sterilizing cabinet (150) also includesa door that opens and closes sterilization chamber (152) in response toactuation of a kick plate (154). An operator may thereby open and closesterilization chamber (152) in a hands-free fashion. Sterilizing cabinet(100) also includes a sterilization module (156) that is operable todispense a sterilant into sterilization chamber (152) in order tosterilize medical devices contained in sterilization chamber (152) asdescribed above. In the present example, sterilization module (156) isconfigured to receive replaceable sterilant cartridges (158) containinga certain amount of sterilant. By way of example only, each sterilantcartridge (158) may contain enough sterilant to perform fivesterilization procedures.

Sterilizing cabinet (150) of the present example further includes atouch screen display (160). Touch screen display (160) is operable torender the various user interface display screens described above andshown in FIGS. 6-17 . Of course, touch screen display (160) may displayvarious other screens as well. Touch screen display (160) is furtherconfigured to receive user input in the form of the user contactingtouch screen display (160) in accordance with conventional touch screentechnology. In addition or in the alternative, sterilizing cabinet (150)may include various other kinds of user input features, including butnot limited to buttons, keypads, keyboards, a mouse, a trackball, etc.

Sterilizing cabinet (150) of the present example further includes aprocessor (162), which is in communication with sterilization module(156) and with touch screen display (160). Processor (162) is operableto execute control algorithms to drive sterilization module (156) inaccordance with user input. Processor (162) is further operable toexecute instructions to display the various screens on touch screendisplay (160); and to process instructions received from a user viatouch screen display (160) (and/or via other user input features). Aswill be described in greater detail below and as shown in FIG. 18 ,processor (162) is also in communication with various other componentsof sterilization cabinet (150) and is thereby operable to drive thosecomponents and/or process input and/or other data from those components.Various suitable components and configurations that may be used to formprocessor (162) will be apparent to those of ordinary skill in the artin view of the teachings herein.

Sterilizing cabinet (150) of the present example further includes acommunication module (164). Communication module (164) is configured toenable bidirectional communication between sterilizing cabinet (150) andcommunication hub (20). In addition or in the alternative, communicationmodule (164) may be configured to enable bidirectional communicationbetween sterilizing cabinet (150) and server (106). By way of exampleonly, communication module (164) may be configured to provide wiredand/or wireless communication via as Ethernet, Wi-Fi, Bluetooth, USB,infrared, NFC, and/or other technologies. Various suitable componentsand configurations that may be used to form communication module (164)will be apparent to those of ordinary skill in the art in view of theteachings herein. Communications that are sent from or received throughcommunication module (164) are processed through processor (162).

Sterilizing cabinet (150) of the present example further includes areader (166), which is operable to read an identification tag of abiological indicator as described herein. It should be understood thatreader (166) may be used to perform the steps of indicator scanning(block 302, block 308) described above with reference to FIG. 3 . By wayof example only, reader (166) may comprise an optical reader that isoperable to read an optical identification tag (e.g., barcode, QR code,etc.) of a biological indicator. In addition or in the alternative,reader (166) may comprise RFID reader that is operable to read an RFIDidentification tag (e.g., barcode, QR code, etc.) of a biologicalindicator. Various suitable components and configurations that may beused to form reader (166) will be apparent to those of ordinary skill inthe art in view of the teachings herein. Data received through reader(166) is processed through processor (162).

Sterilizing cabinet (150) of the present example further includes amemory (168), which is operable to store control logic and instructionsand that are executed by processor (162) to drive components such assterilization module (156), touch screen display (160), communicationmodule (164), and reader (166). Memory (168) may also be used to storeresults associated with setup of a sterilization cycle, performance of aload conditioning cycle, performance of a sterilization cycle, and/orvarious other kinds of information. Various suitable forms that memory(168) may take, as well as various ways in which memory (168) may beused, will be apparent to those of ordinary skill in the art in view ofthe teachings herein.

Sterilizing cabinet (150) of the present example further includes aprinter (170), which is operable to print information such as resultsassociated with setup of a sterilization cycle, performance of a loadconditioning cycle, performance of a sterilization cycle, and/or variousother kinds of information. By way of example only, printer (170) maycomprise a thermal printer, though of course any other suitable kind ofprinter may be used. Various suitable forms that printer (170) may take,as well as various ways in which printer (170) may be used, will beapparent to those of ordinary skill in the art in view of the teachingsherein. It should also be understood that printer (170) is merelyoptional and may be omitted in some versions.

In addition to the foregoing, sterilizing cabinet (150) may beconfigured and operable in accordance with at least some of theteachings of U.S. Pat. No. 6,939,519, the disclosure of which isincorporated by reference herein; U.S. Pat. No. 6,852,279, thedisclosure of which is incorporated by reference herein; U.S. Pat. No.6,852,277, the disclosure of which is incorporated by reference herein;and/or U.S. Pat. No. 6,447,719, the disclosure of which is incorporatedby reference herein.

IV. Exemplary Biological Indicator Assembly

As noted above, a biological indicator may be included in sterilizingcabinet (100, 150) along with the medical device during thesterilization process (block 208) in order to ensure that thesterilization process (block 208) was successful. FIG. 19 shows anexemplary form that such a biological indicator may take. In particular,FIG. 19 shows a biological indicator (700) that includes a housing(710), a cap (720), an ampoule (730), and a carrier (740). Housing (710)is formed of a transparent material (e.g., clear plastic, glass, etc.)and is hollow such that housing (710) insertably receives ampoule (730).Ampoule (730) is also formed of a transparent material (e.g., clearplastic, glass, etc.) and contains a fluid (732). By way of exampleonly, fluid (732) may comprise a liquid growth medium. Such a liquidgrowth medium is capable of, with incubation, promoting growth of anyviable microorganisms it contacts. Fluid (732) also includes afluorophore whose fluorescence depends on the amount of microorganismscontained in the medium. Fluid (732) is sealed within ampoule (730).

Carrier (740) provides a source of microorganisms or active enzymes. Byway of example only, carrier (740) may be impregnated with bacterialspores, other forms of bacteria (e.g., vegetative), and/or activeenzymes. By way of example only, spores from Bacillus, Geobacillus, andClostridium species may be used. Carrier (740) may be water-absorbentand may be formed of filter paper. Sheet-like materials such as cloth,nonwoven polypropylene, rayon or nylon, and microporous polymericmaterials may also be used to form carrier (740). Non-water absorbentmaterials may also be used to form carrier (740), such as metals (e.g.,aluminum or stainless steel), glass (e.g., glass beads or glass fibers),porcelain, or plastic. Of course, combinations of the foregoingmaterials may also be used to form carrier (740).

Ampoule (730) is configured as a frangible component of biologicalindicator (700), such that ampoule (730) may be fractured within housingto release fluid (732) in housing (710). To assist in the fracture ofampoule (730), a set of fracturing features (750) are disposed in thebottom of housing (710). While fracturing features (750) are shown asspikes in FIG. 19 , it should be understood that this is merelyillustrative. Fracturing features (750) may take any other suitableform. To further assist in the fracture of ampoule (730), cap (720) isconfigured to slide downwardly along housing (710) to press ampoule(730) against fracturing features (750). This may be done right beforebiological indicator (700) is inserted into indicator analyzer (102,800) as described in greater detail below. It should be understood thatampoule (730) would remain intact while biological indicator (700) is insterilizing cabinet (100) during a sterilization process. Cap (720) mayinclude one or more openings that allow gasses (e.g., air or sterilant,etc.) to pass into housing (710) before cap (720) is pressed downwardlyrelative to housing (710) to fracture ampoule (730). These openings maythus enable the microorganisms on carrier (740) to be destroyed by thesterilization process (block 208). However, after cap (720) is presseddownwardly relative to housing (710) to fracture ampoule (730), theseone or more openings may be sealed to contain the released fluid (732)in housing (710). When fluid (732) is released from ampoule (730), thereleased fluid eventually reaches carrier (740), thereby initiating anincubation process with any living microorganisms remaining on carrier(740), as will be described in greater detail below.

While not shown in FIG. 19 , housing (710) may also include anidentification tag. Such an identification tag may include a machinereadable feature that is capable of being read by reader (166) ofsterilizing cabinet (100, 150) and biological indicator analyzer (102).In other words, the identification tag may be read perform to the stepsof indicator scanning (block 302, block 308) described above withreference to FIG. 3 . By way of example only, the identification tag maycomprise an optical code (e.g., a barcode, a QR code, etc.), an RFIDtag, and/or any other suitable kind of machine readable identifier. Inaddition, the identification tag may include human readable featuressuch as text, numbers, color coding, etc.

Cap (720) may also include a color changing feature. Such a colorchanging feature may serve as a chemical indicator that changes colorwhen biological indicator (700) is exposed to the sterilant ofsterilizing cabinet (100, 150). In some versions, the color changingfeature simply changes between two distinctive colors, with one of thecolors indicating no exposure to a sterilant and the other colorindicating at least some exposure to a sterilant. In some otherversions, the color changing feature changes along a range of colorsbased on the extent to which biological indicator (700) has been exposedto a sterilant. In other words, the color change may be proportional tothe degree of sterilant exposure.

In addition to or in lieu of the foregoing, biological indicator (700)may be configured and operable in accordance with at least some of theteachings of U.S. patent application Ser. No. 15/057,768, entitled“Self-Contained Biological Indicator,” filed Mar. 1, 2016, thedisclosure of which is incorporated by reference herein. Other suitableforms that biological indicator (700) may take will be apparent to thoseof ordinary skill in the art in view of the teachings herein.

V. Exemplary Biological Indicator Analyzer

A. Exemplary Biological Indicator Analyzer Hardware

FIG. 20 depicts an exemplary set of components that may be incorporatedinto biological indicator analyzer (102). In particular, FIG. 20 showsan exemplary biological indicator analyzer (800) that is operable toperform the biological indicator analysis (block 512) described abovewith reference to FIG. 5 . Biological indicator analyzer (800) of thisexample comprises a plurality of wells (810), each of which isconfigured to insertingly receive a respective biological indicator(700). While two wells (810) are shown, it should be understood that anyother suitable number of wells (810) may be provided, including eightwells (810), less than eight wells (810), or more than eight wells(810). Biological indicator analyzer (800) also includes a processor(820) that is operable to execute instructions and control algorithms,process information, etc.

Each well (810) has an associated light source (830) and sensor (840).Each light source (830) is configured to project light through housing(710) of the biological indicator (700) that is inserted in thecorresponding well (810); and each sensor (840) is operable to detectlight fluoresced by fluid (732) contained in housing (710). By way ofexample only, light source (830) may be in the form of a laser that isconfigured to emit ultraviolet light. Various other suitable forms thatlight source (830) may take will be apparent to those of ordinary skillin the art in view of the teachings herein. By way of further exampleonly, sensor (840) may comprise a charge coupled device (CCD). Variousother suitable forms that sensor (840) may take will be apparent tothose of ordinary skill in the art in view of the teachings herein. Asnoted above, the fluorescence of fluid (732) will depend on the amountof living microorganisms contained in the medium of fluid (732). Thus,sensor (840) will be able to detect the presence of livingmicroorganisms in fluid (732) based on the degree to which fluid (732)fluoresces in response to light from light source (830).

Biological indicator analyzer (800) of the present example furtherincludes a touch screen display (850). Touch screen display (850) isoperable to render various user interface display screens associatedwith operation of biological indicator analyzer (800). Touch screendisplay (850) is further configured to receive user input in the form ofthe user contacting touch screen display (850) in accordance withconventional touch screen technology. In addition or in the alternative,biological indicator analyzer (800) may include various other kinds ofuser input features, including but not limited to buttons, keypads,keyboards, a mouse, a trackball, etc. Displays provided through touchscreen display (850) may be driven by processor (820). User inputsreceived through touch screen display (850) may be processed byprocessor (820).

Biological indicator analyzer (800) of the present example furtherincludes a communication module (860). Communication module (860) isconfigured to enable bidirectional communication between biologicalindicator analyzer (800) and communication hub (20). In addition or inthe alternative, communication module may be configured to enablebidirectional communication between biological indicator analyzer (800)and server (106). By way of example only, communication module (860) maybe configured to provide wired and/or wireless communication via asEthernet, Wi-Fi, Bluetooth, USB, infrared, NFC, and/or othertechnologies. Various suitable components and configurations that may beused to form communication module (860) will be apparent to those ofordinary skill in the art in view of the teachings herein.Communications that are sent from or received through communicationmodule (860) are processed through processor (820).

Biological indicator analyzer (800) of the present example furtherincludes a reader (870), which is operable to read an identification tagof biological indicator (700) as described herein. It should beunderstood that reader (870) may be used to identify biologicalindicator (700) before biological indicator (700) is analyzed (block512). By way of example only, reader (870) may comprise an opticalreader that is operable to read an optical identification tag (e.g.,barcode, QR code, etc.) of a biological indicator. In addition or in thealternative, reader (870) may comprise RFID reader that is operable toread an RFID identification tag (e.g., barcode, QR code, etc.) of abiological indicator. Various suitable components and configurationsthat may be used to form reader (870) will be apparent to those ofordinary skill in the art in view of the teachings herein. Data receivedthrough reader (870) is processed through processor (820).

Biological indicator analyzer (800) of the present example furtherincludes a memory (880), which is operable to store control logic andinstructions and that are executed by processor (820) to drivecomponents such as light source (830), touch screen display (850),communication module (860), and reader (870). Memory (880) may also beused to store results associated with performance of biologicalindicator analysis, and/or various other kinds of information. Varioussuitable forms that memory (880) may take, as well as various ways inwhich memory (880) may be used, will be apparent to those of ordinaryskill in the art in view of the teachings herein.

FIG. 21 shows an exemplary form that indicator analyzer (800) may take.In particular, FIG. 21 shows an indicator analyzer (950) that includes ahousing (952) with a set of eight wells (954), a touch screen display(956), and a reader (960). Housing (952) is configured to sit on atabletop or other horizontal surface and present touch screen (956) atan oblique angle relative to the surface upon which housing (952) rests.Wells (954) are configured and operable like wells (810) describedabove. Touch screen display (956) is configured and operable like touchscreen display (850) described above. Various examples of interactivescreens that may be displayed via touch screen displays (850, 956) willbe described in greater detail below. Reader (960) is configured andoperable like reader (870) described above. It should be understood thatindicator analyzer (950) may further include the other featuresdescribed above with respect to indicator analyzer (800); and mayfurther provide the same functionality and operability described abovewith respect to indicator analyzer (800). Other suitable forms thatindicator analyzer (102, 800, 950) may take will be apparent to those ofordinary skill in the art in view of the teachings herein.

B. Exemplary Biological Indicator Processes and Interfaces

FIG. 22 shows an exemplary set of steps that may be used to initiatebiological indicator (700) analysis cycle by biological indicatoranalyzer (102, 800, 950). As a first step, the user may observe whichwells (810, 954) are vacant (block 900) and select a vacant well (block902). In some versions, touch screen display (850, 956) presents anumber next to each vacant well (810, 954), such that the operatorsimply touches the number associated with the selected vacant well (810,954) in order to effect selection of that vacant well (block 902). Next,a display screen on touch screen display (850, 956) may prompt the userto place the identification tag of biological indicator (700) nearreader (870, 960) to enable reader (870, 960) to read the identificationtag of biological indicator (700). As part of this prompting, touchscreen display (850, 956) may point to the location of reader (870, 960)to assist the user in finding reader (870, 960). The user may then usereader (870, 960) to read the identification tag of biological indicator(700) (block 904).

A display screen on touch screen display (850, 956) may then prompt theuser to identify himself or herself. The user may then manipulate touchscreen display (850, 956) to identify himself or herself (block 906). Adisplay screen on touch screen display (850, 956) may then prompt theuser to indicate whether the chemical indicator on cap (720) ofbiological indicator (700) has changed color. The user may thenmanipulate touch screen display (850, 956) to indicate whether thechemical indicator on cap (720) of biological indicator (700) haschanged color (block 908).

A display screen on touch screen display (850, 956) may then prompt theuser to prepare biological indicator (700) for loading into the selectedwell (810, 954) by fracturing ampoule (730) and shaking biologicalindicator (700). The operator may then fracture ampoule (730) bypressing on cap (720), then shake biological indicator (700) (block 910)to ensure proper mixing of fluid (732) with carrier (740). The user maythen quickly place biological indicator (700) in the selected well (810,954) (block 912). In some instances it may be desirable to insertbiological indicator (700) in the selected well (810, 954) (block 912)immediately after fracturing ampoule (730) and shaking biologicalindicator (700) (block 910).

In some versions, indicator analyzer (102, 800, 950) is configured todetermine whether the user appropriately completed the step offracturing ampoule (730) and shaking biological indicator (700) (block910) before inserting biological indicator (700) in the selected well(810, 954) (block 912). By way of example only, this may be determinedbased on how sensor (840) detects light emitted by light source (830)after biological indicator (700) is inserted in the selected well (810,954). In the event that indicator analyzer (102, 800, 950) determinesthat the user failed to appropriately complete the step of fracturingampoule (730) and shaking biological indicator (700) (block 910) beforeinserting biological indicator (700) in the selected well (810, 954)(block 912), touch screen display (850, 956) may prompt the user towithdraw biological indicator (700) from well (810, 954) and properlycomplete the step of fracturing ampoule (730) and shaking biologicalindicator (700) (block 910).

To the extent that the user has properly completed the step offracturing ampoule (730) and shaking biological indicator (700) (block910), and then inserted biological indicator (700) in the selected well(block 912), biological indicator (700) is allowed to sit in well (810,954) for an incubation period (block 914). During the incubation period(block 914), light source (830) associated with the selected well (810,954) is activated and sensor (840) monitors responsive fluorescence offluid (732) in indicator (700). Well (810, 954) may also be heated(e.g., to approximately 60° C.) during the incubation period (block914). As noted above, fluid (732) includes a fluorophore whosefluorescence depends on the amount of microorganisms contained in themedium. Thus, sensor (8400 can detect the presence of livingmicroorganisms (from carrier (740)) in fluid (732) based on thefluorescence of fluid (732). It should therefore be understood that,after a suitable incubation period has passed, indicator analyzer (102,800, 950) will conclude whether any of the microorganisms that were oncarrier (740) (i.e., before the sterilization cycle in sterilizationcabinet (100, 150)) survived the sterilization cycle in sterilizationcabinet (100), based on the fluorescence of fluid (732) as sensed bysensor (840).

By way of example only, the incubation period (block 914) may beapproximately 30 minutes. Alternatively, the incubation period may besubstantially longer (e.g., one or more hours), shorter, or of any othersuitable duration. During the incubation period (block 914), touchscreen display (850, 956) may provide a graphical representation of theamount of time remaining in the incubation period. When more than onewell (810, 954) is occupied by a corresponding biological indicator(700), touch screen display (850, 956) may provide a graphicalrepresentation of the amount of time remaining in the incubation periodfor each occupied well (810, 954).

FIG. 23 shows a set of exemplary steps that may be carried out once theincubation period (block 914) is complete. As noted above, biologicalindicator analyzer (102, 800, 950) can determine whether any of themicroorganisms that were on carrier (740) (i.e., before thesterilization cycle in sterilization cabinet (100, 150)) survived thesterilization cycle in sterilization cabinet (100), based on thefluorescence of fluid (732) as sensed by sensor (840). Thus, biologicalindicator analyzer (102, 800, 950) can determine whether biologicalindicator (700) passes or fails analysis (block 1000). In this sense, a“pass” result indicates that no living microorganisms are present inbiological indicator (700), which indicates that the sterilization cycle(block 208) in sterilization cabinet (100) was successful. A “fail”result indicates that living microorganisms are present in biologicalindicator (700), which indicates that the sterilization cycle (block208) in sterilization cabinet (100) was unsuccessful.

In the event of a “pass” result, touch screen display (850, 956) maypresent a screen to the user indicating that biological indicator (700)passed the analysis (block 1002). Touch screen display (850, 956) mayalso prompt the user to remove biological indicator (700) from well(810, 954) (block 1004) and appropriately discard the used biologicalindicator (700). As described in greater detail below, biologicalindicator analyzer (102, 800, 950) may also transmit the “pass” result(and associated data) to communication hub (20) (block 1006) viacommunication module (860). In some versions, this transmission of the“pass” result (and associated data) to communication hub (20) (block1006) is done in response to a query from communication hub (20), suchthat the “pass” result (and associated data) is pulled from biologicalindicator analyzer (102, 800, 950) by communication hub (20). In someother versions, the “pass” result (and associated data) is pushed tocommunication hub (20) (block 1006) by biological indicator analyzer(102, 800, 950), without requiring a query from communication hub (20).

In the event of a “fail” result, touch screen display (850, 956) maypresent a screen to the user indicating that biological indicator (700)failed the analysis (block 1010). Touch screen display (850, 956) maythen prompt the user to identify himself or herself. The user may thenmanipulate touch screen display (850, 956) to identify himself orherself (block 1012). Touch screen display (850, 956) may then promptthe user to remove biological indicator (700) from well (810, 954)(block 1014) and appropriately discard the used biological indicator(700). As described in greater detail below, biological indicatoranalyzer (102, 800, 950) may also transmit the “fail” result (andassociated data) to communication hub (20) (block 1016) viacommunication module (860). In some versions, this transmission of the“fail” result (and associated data) to communication hub (20) (block1016) is done in response to a query from communication hub (20), suchthat the “fail” result (and associated data) is pulled from biologicalindicator analyzer (102, 800, 950) by communication hub (20). In someother versions, the “fail” result (and associated data) is pushed tocommunication hub (20) (block 1016) by biological indicator analyzer(102, 800, 950), without requiring a query from communication hub (20).

FIG. 24 shows a set of exemplary high level steps that may be performedby an indicator analyzer (102, 800, 950) to employ the use of anexperimental control when testing a biological indicator (700) from apreviously performed sterilization cycle. When a user selects anindicator (700) to scan, indicator analyzer (102, 800, 950) will verify(block 212) that a control indicator has been analyzed from the same lotor group as the selected indicator (700) by accessing data from server(106) via communication hub (20). A control indicator (700) is a normalbiological indicator (700) that has been selected from a group ofassociated biological indicators (700) and analyzed without first beingrun through a sterilization cycle and, if the group that the control hasbeen selected from are viable indicators (700), will result in anindication of positive for contamination since it has not beensterilized. By testing a control from a group of indicators (700), auser may minimize the chance that a group of indicators (700) that havebeen stored or handled incorrectly will be unwittingly used with thesystem. By building controls to verify (block 212) that a control hasbeen run for the selected indicator (700), the system can partiallyautomate and enforce control testing. Once a control indicator (700) hasbeen verified (block 212), the test indicator (700) may be analyzed(block 214) by indicator analyzer (102, 800, 950) by placing indicator(700) in a test well (810, 954) and allowing indicator analyzer (102,800, 950) to incubate and analyze (block 214) the biological contents ofindicator (700) to determine if contaminants survived a sterilizationcycle. Once results are available from a test (block 214), the test maybe finalized (block 216) by displaying results via touch screen display(850, 956) of the indicator analyzer (102, 800, 950), providing guidanceor recommendations based upon the results; and transmitting results viathe communication hub (20) to sterilizing cabinet (100, 150), to server(106), or to both.

FIG. 25 shows a set of exemplary steps that may be performed byindicator analyzer (102, 800, 950) to verify and enforce the use of acontrol indicator (700). A user may begin configuring an indicator testby making a selection via a user interface, such as touch screen display(850, 956) of indicator analyzer (102, 800, 950), resulting in a well(810, 954) selection and indicator (700) selection being received (block218) by indicator analyzer (102, 800, 950). As noted above, indicatoranalyzer (102, 800, 950) may have multiple testing wells (810, 954) thatcan receive an indicator (700) and perform incubation and analysis suchthat multiple indicators (700) may be processed simultaneously. Theindicator selection may be performed by scanning or reading a machinereadable code or unique identifier on an indicator (700), using reader(870, 960); or by manual entry of indicator (700) information to allowindicator analyzer (102, 800, 950) to identify indicator (700).Identifying indicator (700) allows indicator analyzer (102, 800, 950) toaccess records on server (106) via communication hub (20) to determinewhether the identified indicator (700) comes from a batch or group ofindicators (700) that has been control tested; to determine if indicator(700) has already been incubated and analyzed and prevent erroneousretesting; or to identify a sterilization cycle that was performed withindicator (700).

FIG. 28 shows a screenshot of an exemplary user interface for making awell (810, 954) selection. In the exemplary interface, eight differentnumbered wells (810, 954) are represented numerically and are selectableby interacting with the well number (418) (e.g., by tapping on the wellnumber (418)) for the desired well (810, 954). An exemplary userinterface may be displayed for selecting whether the selected well (810,954) will receive a control indicator (700), by interacting with a“control” indicator button; or a test indicator (700), by interactingwith a “test” indicator button. An exemplary user interface may bedisplayed for providing guidance to a user for scanning a machineidentification from an indicator (700) via reader (870, 960) ofindicator analyzer (102, 800, 950).

FIG. 29 shows a screenshot of an exemplary user interface for providingfurther guidance to a user (472) for scanning a machine identificationfrom an indicator (700) via reader (870, 960) of indicator analyzer(102, 800, 950). This guidance may include activation of an arrowpointing to the location of reader (960) on indicator analyzer (950),with textual instructions on how to position indicator (700) in relationto reader (870, 960). In some versions, if an indicator analyzer (102,800, 950) is being used in a setting where it cannot immediatelycommunicate with server (106), or if reader (870, 960) is not available,identification information and sterilization cycle information may beentered manually via a user interface that has manual entry boxes forinputting indicator (700) information and cycle information (e.g.,identifying the particular sterilizing cabinet (100), the sterilizationcycle type, the sterilization cycle number, the sterilization cyclestart time, the sterilization cycle end time, etc.). This additionalinformation will provide a link between a particular indicator (700) anda sterilization cycle that was previously carried out using sterilizingcabinet (100, 150).

Once a well (810, 954) has been selected and an indicator (700) type hasbeen selected (block 218), indicator analyzer (102, 800, 950) may queryrecords from server (106) and identify a lot or group associated withthe selected or scanned indicator (700) in order to determine if therehas been a recent control indicator (700) analyzed from that lot orgroup (block 220). For example, if indicators (700) come in lots of 24,each of the 24 indicators (700) was likely manufactured at approximatelythe same time, from the same components, and was likely to be packaged,shipped, stored, and otherwise handled in a similar manner. Therefore,if a single indicator (700) from the lot of 24 is tested as a controlindicator (700) and fails to report as positive for contamination, itmay be likely that other indicators (700) from the same lot may beflawed as well, such that those indicators (700) should be discarded inorder to avoid false negatives that would erroneously suggest thatsterilization cycles were successful. The system may be configured sothat indicator analyzer (102, 800, 950) requires a control indicator(700) to be analyzed for each lot, and the results recorded to server(106) and associated with the lot, so that the system can later verifythe control (block 220). In some versions a control indicator (700) maybe required once per lot, or once every 24 hours per lot, or any othervariation on numbers per lot, durations of time between re-testing ofcontrol, or other similar configurable testing requirement.

If it is determined that control requirements have been met for the lotof the selected indicator (block 220), the control has been verified andthe system may prompt the user to proceed with testing of selected testindicator (700). If it is determined that control requirements for thelot have not been met (block 220), the system will instead notify theuser of the requirement for a control to be performed and guide the userthrough inserting a control indicator (700) from the selected lot intothe selected well (810, 954). The system may additionally verify thechemical indicator (block 224) of the control indicator (700) via aninterface screen that shows a graphic providing the difference in visualappearance between an unchanged chemical indicator and a changedchemical indicator. A chemical indicator of biological indicator (700)is initially a first color; but during a sterilization cycle a chemicalreaction to temperatures or substances used during sterilization causesthe chemical indicator to change to a second color, providing a visualindication as to whether a particular indicator (700) has undergone asterilization cycle. Therefore, the interface described above allowsuser to verify and indicate that a control indicator (700), which hasnot undergone a sterilization cycle, is still showing an original colorthrough its chemical indicator. If a user selects otherwise, the systemmay prompt the user to select a different control indicator (700), asthe previously selected control indicator (700) is either flawed or hasbeen used in sterilization cycle.

Once the chemical indicator has been verified by the user and system(block 224), the system will begin to incubate the control indicator(block 226) after the control indicator (700) is inserted into theselected well (810, 954). Each well (810, 954) of indicator analyzer(102, 800, 950) may be equipped with a button, photo eye, or othersensor that allows it to determine when an indicator (700) is insertedinto well (810, 954) so that incubation may automatically begin. In someversions, light source (830) and sensor (840) are used to determine whenan indicator (700) is inserted into well (810, 954). Various suitableways in which the presence of an indicator (700) in a well (810, 954)may be sensed will be apparent to those of ordinary skill in the art inview of the teachings herein.

FIG. 30 shows a user interface that could be displayed to provideupdates to a user for each well (810, 954) of an indicator analyzer(102, 800, 950). In FIG. 30 , eight wells (810, 954) are shown invarying states, with the incubation and analysis progress of each well(810, 954) shown by an incrementing series of dashes or other symbols(429); or with a colored circle or symbol (427) to indicate a recentchange in status for a well (810, 954) that has recently startedincubation or analysis, or has recently completed incubation oranalysis. Selecting a particular well (810, 954) via the user interfaceof FIG. 30 may cause indicator analyzer (102, 800, 950) to display amore detailed status screen for the selected well (810, 954) that showsthe type of test being performed (431) so that a user may determinewhether well (810, 954) is running a control indicator (700) or a testindicator (700), and a more detailed time status so that a user may geta more accurate picture of the remaining time for the incubation andanalysis.

Once control indicator (700) incubation and analysis is complete (block226), indicator analyzer (102, 800, 950) will determine if controlindicator (700) tests positive for contamination, which indicates thatthe control indicator passed. If control indicator (700) results pass(block 228), the control indicator (700) results may be displayed (block230) via touch screen display (850, 956) of indicator analyzer (102,800, 950) and transmitted to server (106) to be associated with the lotfrom which the control indicator (700) was selected so that future testindicators (700) from that lot may be analyzed without interruption. Ifit is determined that the control failed (block 228), the system willnotify a user of the failure via a user interface that indicates thewell (810, 954) where the failed control indicator (700) is placed. Ifit is a first control failure (block 232), the system will indicate thatit is a first failure and prompt the user to change wells (810, 954) andtest a second control indicator (block 234).

An interface could be shown in the event of a first control indicator(700) failure. By way of example only, such an interface may provideadditional guidance to a user to identify the lot that the secondcontrol should be selected from; as well as which well (180, 954) toavoid using in a second control. Performing a second control indicator(700) test in a different well (180, 954) allows the system to isolatefor a malfunctioning test well (180, 954).

As another merely illustrative example, an interface may allow foridentifying a user and guiding the user through performing a secondcontrol indicator analysis. The user identification may be used bysystem administrators to audit the results of the control indicator(700) analysis and ensure that proper steps are taken in the event of acontrol indicator (700) failure. Following the provided directions, theuser may select a new control indicator (700) and return to the step ofverifying the chemical indicator (block 224). If proceeding through thesteps results in a second control failure (block 228), the system mayinstead prompt the user to discard the lot from which the previousfailed controls were selected from and run a control and test indicator(700) from a different lot (block 236), which may require that the userrerun a sterilization cycle for affected medical devices with a new testindicator (700) from a different lot so that a valid control can beperformed for the lot (block 220).

An interface could be displayed in the event of a second controlindicator (700) failure. By way of example only, such an interface mayprovide the user with guidance for handling the second control indicator(700) failure. An additional user interface may be used to identify auser for audit purposes and provide additional guidance in the event ofa second control indicator failure.

FIG. 26 shows a set of exemplary steps that may be performed byindicator analyzer (102, 800, 950) to perform an incubation and test(block 214) on a test indicator (700) after a control indicator (700)has been verified (block 212). Initially, indicator analyzer (102, 800,950) may verify that the chemical indicator of test indicator (700)shows positive for having undergone a sterilization cycle (block 237).In some instances, touch screen display (850, 956) may provide aninterface screen that provides a user with guidance as to whether achemical indicator is showing an original color or is showing a colorindicative of a sterilization cycle; and to receive a selection from theuser verifying that the chemical indicator shows positive (block 237)for having undergone a sterilization cycle. Such an interface screen mayinclude graphical representations of indicator (700) with the differentcolors, with associated input buttons to indicate which color is beingobserved by the user.

Indicator analyzer (102, 800, 950) may also verify indicator (700)activation with the user (block 238) via a user interface such as thatshown in FIG. 31 , which provides an illustrated guide (446) foractivating and verifying activation of a test indicator (700) prior toincubation and analysis, and for receiving a selection from the userverifying activation (block 238). After indicator activation has beenverified (block 238), indicator (700) may be placed (block 240) into theselected test well (810, 954). An interface could be displayed to prompt(block 242) a user to place indicator (700) in the selected test well(810, 954) via a textual and/or graphic instruction, if a sensor of testwell (810, 954) does not detect that indicator (700) has been placed(block 240). When a sensor of test well (810, 954), such as a button orphoto eye, determines that indicator (700) has been placed (block 240),the incubation may be performed (block 244).

While waiting for the incubation to complete (block 246), indicatoranalyzer (102, 800, 950) will update well display screens (block 248)regularly so that users may review information on active wells (810,954). FIG. 32 shows an example of a user interface that could bemaintained and updated (block 248) to reflect current information onwell (810, 954) status. In particular, FIG. 32 shows a user interfacethat could be displayed via touch screen display (850, 956) of indicatoranalyzer (102, 800, 950) to provide more verbose information (450) on anindicator (700) currently being incubated and analyzed in a well (810,954). Such verbose information could include, for example, the type ofbiological indicator (700) that is being analyzed, such as a controlindicator (700) or test indicator (700), lot number from which indicator(700) was selected, serial number, expiration date, user identification,time that incubation began, date of incubation, verification of chemicalindicator status, temperature of incubator, result of incubation andanalysis if available, sterilization cycle associated with indicator(700), cycle type, cycle number, cycle start and end time, and otherinformation that may desirably be displayed via indicator analyzer (102,800, 950).

When incubation is complete (block 246) indicator analyzer (102, 800,950) may analyze the incubated indicator (700) and determine if anybiological contaminants developed or remain after the incubation (block250). As noted above, in some versions, indicator (700) will contain aliquid solution that will react to biological contaminants such that ifa first color is shown there is no contamination, indicating that thesterilization cycle was successful; and if a second color is shown thereis contamination, indicating that the sterilization cycle failed. Insuch versions, analysis of whether indicator (700) is positive ornegative for contamination may be performed by use of light source (830)and sensor (840), to detect fluorescence by indicator (700), asdescribed above.

FIG. 27 shows a set of exemplary steps that may be performed to displaytest results and finalize a test (block 216). If the indicator analysis(block 250) indicates that the test indicator (700) is negative forcontamination, then indicator (700) has passed (block 252) and indicatoranalyzer (102, 800, 950) may update the well display interface toindicate to the user that a test indicator (700) has passed (block 254).An interface could be displayed to indicate to a user that a well of theindicator analyzer (102, 800, 950) has completed a with a negativecontamination result. The well indicator may be configured with aspecific color signifying success, such as green; and/or may include aparticular symbol signifying success, such as a checkmark, star, orother symbol, color, or visual indicator.

An interface may be displayed to give a user a more detailed descriptionand guidance after a passed indicator (block 252). Indicator analyzer(102, 800, 950) may then detect when indicator (700) is removed from thetest well (block 256) via a sensor situated in test well (810, 954); anddisplay and transmit results (block 258) of the test indicator analysis.In some versions, the results are transmitted (block 258) from indicatoranalyzer (102, 800, 950) to communication hub (20) in response to aquery from communication hub (20), such that the results are pulled frombiological indicator analyzer (102, 800, 950) by communication hub (20).In some other versions, the results are pushed to communication hub (20)(block 258) by biological indicator analyzer (102, 800, 950), withoutrequiring a query from communication hub (20).

An interface may be displayed for providing a detailed summary of testresults including information such as whether the completed test was fora control indicator (700) or a test indicator (700), a lot number fromwhich indicator (700) was selected, serial number, expiration date, andother similar information as is shown and described in relation to sucha status interface and other similar figures. The same interface mayprovide information on the sterilization cycle, including but notlimited to an identification of the sterilization cabinet (100) in whichthe sterilization cycle was performed, the type of sterilization cycleperformed, the sterilization cycle number, the sterilization cycle starttime, the sterilization cycle end time, etc. Results of the testindicator analysis may additionally be printed, stored locally onindicator analyzer (102, 800, 950), transmitted to a sterilizing cabinet(100, 150) via communication hub (20), and/or transmitted to a remoteserver (106) via communication hub (20).

If the indicator analysis (block 250) instead indicates that indicator(700) is positive for contamination, the system determines thatindicator (700) failed (block 260) and may update the well display ofindicator analyzer (102, 800, 950) to reflect the failure (block 262).An interface could be displayed to indicate to a user that an indicator(700) in a specific well failed, and to receive a confirmation oracknowledgment of the failure from the user.

An interface may be displayed to a user after an indicator (700) failure(block 260) in order to provide additional information and guidance forthe user. Another interface may be displayed to a user in order toreceive (block 264) an identification of the user for audit and followup purposes, and to provide (block 266) additional guidance onquarantine and re-sterilization procedures for affected equipment.Identification of the user (block 264) may be useful where anadministrator later wishes to ensure that quarantine procedures werecorrectly followed. An interface could be displayed in order to receivea confirmation from a user that quarantine procedures or instructionswere read and acknowledged. (block 266). Indicator analyzer (102, 800,950) may then display a user interface in order to prompt a user toremove the failed indicator. Indicator analyzer (102, 800, 950) maydetect the removal of the indicator (block 268) via a sensor ofindicator analyzer (102, 800, 950) and display and transmit test results(block 270) in response. In some versions, the results are transmitted(block 270) from indicator analyzer (102, 800, 950) to communication hub(20) in response to a query from communication hub (20), such that theresults are pulled from biological indicator analyzer (102, 800, 950) bycommunication hub (20). In some other versions, the results are pushedto communication hub (20) (block 270) by biological indicator analyzer(102, 800, 950), without requiring a query from communication hub (20).

Another interface could be displayed to provide a verbose summary oftest results that could include information such as test type, lotnumber, serial number, lot expiration date, sterilization cycleinformation, and additional information. Information generated from thefailed test may also be printed, stored locally on the indicatoranalyzer (102, 800, 950), or transmitted to one or more of the server(106) and sterilizing cabinet (100, 150) via the communication hub (20).Test results from a failed test may be used by sterilizing cabinet (100,150), the server (106), or both to identify medical devices that mayneed to be quarantined or re-sterilized, to identify sterilizingcabinets (100, 150) that are malfunctioning, to identify users that arenot following proper sterilization procedures, or to identify otherassociations with data stored on server (106) or sterilizing cabinet(100, 150) that may be used to improve the effectiveness of futuresterilization cycles.

C. Exemplary Enzyme Analysis Methods

As discussed above, indicator analyzer (102, 800, 950) is configured toanalyze biological indicators (700) in order to determine whether activeenzymes are present in fluid (732), by detecting fluorescence of fluid(732). This is accomplished by activating light source (830) and usingsensor (840) to detect any fluorescence in fluid (732) in response toillumination from light source (830) during the incubation period inwell (810, 954). FIG. 33 shows the fluorescence of a first group (1200)of biological indicators (700) over a period time (i.e., during anincubation period), as detected by indicator analyzer (102, 800, 950).The biological indicators (700) of first group (1200) were subject to anon-efficacious sterilization cycle in sterilization cabinet (100, 150).In FIG. 33 , the fluorescence is shown in relative fluorescence units(RFUs), which are known units of measurement. As can be seen, thefluorescence value drops during the initial part of the incubationperiod. By way of example only, this drop in fluorescence may be due toheating of fluid (732) in well (810, 954) of indicator analyzer (102,800, 950). After this initial drop, the fluorescence value increasesover the remainder of the incubation period. This increase influorescence value indicates that each biological indicator (700) of thefirst group (1200) contains an active enzyme. Thus, the sterilizationprocesses encountered by biological indicators (700) of the first group(1200) were failures.

FIG. 34 shows the fluorescence of a second group (1202) of biologicalindicators (700) over a period time (i.e., during an incubation period),as detected by indicator analyzer (102, 800, 950). The biologicalindicators (700) of second group (1202) were subject to an efficacioussterilization cycle in sterilization cabinet (100, 150). In FIG. 34 ,the fluorescence is again shown in relative fluorescence units (RFUs).As can be seen, the fluorescence value drops during the initial part ofthe incubation period. As noted above, this drop in fluorescence may bedue to heating of fluid (732) in well (810, 954) of indicator analyzer(102, 800, 950). After this initial drop, the fluorescence value stayssubstantially constant over the remainder of the incubation period. Thisconstancy in fluorescence value indicates that none of the biologicalindicators (700) of the second group (1202) contains an active enzyme.Thus, the sterilization processes encountered by biological indicators(700) of the second group (1202) were successful.

In order to determine whether the fluorescence of biological indicators(700) will increase or remain substantially constant after the initialpart of the incubation period where the fluorescence value drops, it maybe desirable to monitor the fluorescence value for a substantial periodof time in order for the results of the analysis to be sufficientlyreliable or trustworthy. In other words, it may be desirable to continuemonitoring the fluorescence value for a substantial period of time afterthe initial part of the incubation period where the fluorescence valuedrops, in order to determine with sufficient certainty that thefluorescence value has increased to a point indicating that activeenzyme is present (indicating failure of the sterilization process); orthat the fluorescence value has remained substantially constantindicating that no active enzyme is present (indicating success of thesterilization process). There may also be a competing interest inproviding the analysis as quickly as possible in order to provide asatisfactory wait time for the end user. Thus, it may be desirable toprovide analysis of biological indicators (700) as quickly as possiblewithout compromising the reliability of the results of such analysis.

In order to speed up the analysis of biological indicators (700), it maybe desirable to find the point at which the rate of product creation isat its maximum, then compare the maximum rate to a critical value. Withan excess of substrate relative to enzyme concentration, this maximumrate may be directly related to the amount of enzyme present and therebyto the efficaciousness of the sterilization cycle.

As can be observed in FIGS. 33 and 34 , the slopes of the curves arefairly constant after the initial drop. FIG. 35 shows the change in theslope over 15 minute increments of the data in FIGS. 33 and 34 . As canbe seen in FIG. 35 , after about 20 minutes the slope reaches a maximumrate and then holds there for the two-hour incubation period. Whilethere is some noise in the reading, there is not a significant increasein the slope after 20 to 30 minutes. FIG. 35 also clearly illustratesthe difference in the maximum slope for the first group (1200) versusthe second group (1202). In particular, the average maximum slope forthe first group (1200) is greater than 10,000; while the average maximumslope for the second group (1202) is approximately 1,600. This slopediscrepancy is large enough that it may be easily detected in a reliablefashion. Moreover, this slope discrepancy may be detected rather quickly(e.g., on the order of approximately 20-30 minutes).

In view of the foregoing, rather than only tracking absolutefluorescence values, it may be beneficial to track the slopes associatedwith changes in fluorescence values. Tracking the slopes may providerelative rapid yet reliable analysis indicating whether a biologicalindicator (700) was subject to an efficacious sterilization cycle or anon-efficacious sterilization cycle. To this end, after an incubationperiod has begun in indicator analyzer (102, 800, 950), indicatoranalyzer (102, 800, 950) may initially monitor the fluorescence ofbiological indicator (700) and calculate the slope. Indicator analyzer(102, 800, 950) may then compare the slope against a critical value(e.g., some number that is greater than 1,600, such as 2,000; 5,000;7,500; etc.). If the slope is greater than the critical value, thenindicator analyzer (102, 800, 950) may conclude that an active enzyme ispresent in biological indicator (700); and trigger any of the varioussterilization process failure notifications described herein. If theslope is less than the critical value, then indicator analyzer (102,800, 950) may continue to monitor the slope until the slope reaches amaximum value. By way of example only, it may take approximately 20 to30 minutes for the slope to reach a maximum value. If the slope is stillless than the critical value at this stage, then indicator analyzer(102, 800, 950) may conclude that no active enzyme is present inbiological indicator (700); and trigger any of the various sterilizationprocess success notifications described herein.

While the foregoing examples have been provided in the context ofmonitoring fluorescence of fluid (732) in biological indicator (700), itshould be understood that the same concepts may be readily applied toother detectable parameters (e.g., iridescence, absorbance, etc.) thatchange based on the presence of an active enzyme in fluid (732).Similarly, while the foregoing examples have been provided in thecontext of biological indicators (700) that have undergone sterilizationprocesses in sterilization cabinet (100, 150), it should be understoodthat the same concepts may be readily applied to any sterilizationmodality that uses an enzymatic reaction and/or in various other kindsof enzyme detection contexts.

FIGS. 36-37 show additional plots of fluorescence (in units of RFU) overtime to illustrate additional exemplary methods of determining whetheran active enzyme is present in fluid (732) of biological indicator(700). Just like the method described above with respect to FIGS. 33-35, the methods described below may be carried out using indicatoranalyzer (102, 800, 950). The methods associated with FIGS. 36-37 seekto filter out fluorescence data associated with the initial part of theincubation process where the fluorescence value encounters the initialdrop (e.g., due to heating of fluid (732) in well (810, 954)). In bothof the following examples, the variable t′ is defined as the time atwhich the fluorescence value has completed the initial drop.

In the graph shown in FIG. 36 , the curve (1210) is a plot associatedwith a biological indicator (700) having an active enzyme (indicating anon-efficacious sterilization cycle); while the curve (1212) is a plotassociated with a biological indicator (700) lacking an active enzyme(indicating an efficacious sterilization cycle). The line (1214) is ahorizontal line drawn parallel to the x-axis (which represents time), atthe value associated with the initial fluorescence of biologicalindicator (700). The lower limit of the integral formula shown in FIG.36 , t₁, is taken at the point where line (1214) intersects curve (1210,1212). The test statistic is given by the integral shown in FIG. 36 .

In the graph shown in FIG. 37 , the curve (1210) is again a plotassociated with a biological indicator (700) having an active enzyme(indicating a non-efficacious sterilization cycle); while the curve(1212) is again a plot associated with a biological indicator (700)lacking an active enzyme (indicating an efficacious sterilizationcycle). The line (1214) is again a horizontal line drawn parallel to thex-axis (which represents time), at the value associated with the initialfluorescence of biological indicator (700). Again, the lower limit ofthe integral formula shown in FIG. 37 , t₁, is taken at the point whereline (1214) intersects curve (1210, 1212). However, in this example t′is defined as the time at which the negative area (1220) (i.e., the areaunder line (1214) before reaching t₁) is halved; or alternatively at thecentroid of the negative area (1220). This does not necessarily requirefinding the precise minimum value in curve (1210, 1212), but it stillyields an integration starting point where the biologically relevantluminous intensity or fluorescence begins. The integration is thenperformed on the luminous intensity or fluorescence taken from t₁ tot_(f), which represents the end of the incubation period analysis cycle,to generate the test statistic. As shown, this determines the areabetween curve (1210, 1212) and a new horizontal line (1216). Thishorizontal line is parallel to the x-axis and is at the value associatedwith the minimum fluorescence value associated with time t′.

Regardless of whether the test statistic is evaluated using the methoddescribed above with respect to FIG. 36 or the method described abovewith respect to FIG. 37 , the test statistic may be compared to apredefined critical value. The critical value would serve as a thresholdindicating whether biological indicator (700) contains an active enzymeor lacks an active enzyme. It should be understood that curve (1210)would yield a test statistic that exceeds the critical value, therebyindicating a non-efficacious sterilization cycle; while curve (1212)would yield a test statistic that falls below the critical value,thereby indicating an efficacious sterilization cycle. It should also beunderstood that the “trapezoidal method” may be used to performintegration in accordance with the methods described above. Varioussuitable ways in which a critical value may be identified for thepurposes described herein will be apparent to those of ordinary skill inthe art. It should also be understood that the fluorescence ofbiological indicators (700) may be analyzed using other techniques.

VI. Exemplary Communication Hub Device and Methods

A. Exemplary Communication Hub Device

FIG. 39 shows a schematic view of an exemplary communication hub (20)that may be used within system (10) to provide monitoring of andcommunication with one or more other devices (100, 102, 106) via a userdevice (108). Communication hub (20) shown in FIG. 39 includes a housingor case (110) containing a processor (1600) and memory (1602) forstoring and manipulating data, and a network interface (1608) forcommunicating with outside devices such as the various devices (100,102, 106, 108) shown in FIG. 1 . Memory (1602) may include one or moreof a random access memory, a read only memory, a volatile memory, anon-volatile memory, an internal hard drive, an external hard drive, aUSB storage device, a flash memory storage device, a network storagedevice, and/or other similar forms of memory. Network interface (1608)may allow a wired connection between two or more devices, such as byEthernet, USB, fiber optic, and/or other wired data transmission medium;and/or may allow wireless connection between two or more devices, suchas by Wi-Fi, Bluetooth, radio transmission, or other wireless datatransmission medium.

FIG. 39 shows a version of a communication hub (20) that does not have adisplay, keyboard, or other interface that a user directly interactswith. Instead, that communication hub (20) may be in communication witha user device (108) via the network interface (1608), and a user mayinteract with the communication hub (20) via a display (1606) and userinput (1604) of the user device (108). In this manner, the communicationhub (20) may provide information to the user device (108), which theuser device (108) may render via a display (1606) such as a computermonitor or mobile device touch screen. Communication hub (20) mayfurther receive user input from the user device (108) via a user input(1604) such as a keyboard, mouse, or other input device. This allows auser to, for example, use a device (108) such as a laptop computer toview information and configurations of other devices in communicationwith hub (20), such as sterilizing cabinet (100) and biologicalindicator analyzer (102), on the laptop display (1606); and to navigateand modify such configurations and information via the laptop keyboardand mouse (1604).

Other devices or features that may be present in a user device (108) orconnected to a user device include an alternate input (1614) such as animaging scanner, microphone, NFC or RFID scanner, and similar inputdevices, a printer (1612), and an alternate output device (1610), suchas a speaker, indicator light, vibration function, or similar outputdevices. With such additional devices or features, information andconfiguration from devices connected to communication hub (20) may beprinted via a printer (1612) so that hard copies are available. Analternate user input (1614) such as an imaging scanner may be used toread barcodes or other image identifiers from a device to assist inidentifying devices, connecting to devices, or changing configurationson devices. An alternate output (1610) may be used to provide additionalforms of notification or feedback to a user, such as providing anaudible alarm when a device unexpectedly loses connection tocommunication hub (20). Other examples of devices or features that maybe present in communication hub (20) or a user device (108) incommunication with hub (20) will be apparent to those of ordinary skillin the art in light of the disclosure herein.

While such features and components may be spread across several devices,such as a combination of a communication hub (20) and user device (108)as shown in FIG. 39 , such features and components may alternatively beintegrated into a single device such as the communication hub (20) ofFIG. 40 . In the exemplary hub of FIG. 40 , communication hub (20) maybe a proprietary device such as a kiosk or other piece of specializedequipment, or may be a computer or server configured with additionalcomponents. Such a communication hub (20) may contain or be directlyconnected to a processor (1601), memory (1602), user interface (1604),display (1606), network interface (1608) alternate output (1610),printer (1612), and alternate input (1614) having the capabilitiesdescribed above or otherwise as will be apparent to one of ordinaryskill in the art in light of the disclosure herein. Such a communicationhub (20) could be, for example, a specially built kiosk containing oneor more of the listed components in a single case, body, or frame, butcould also include, for example, a computer or server having a memory,processor, and wireless communication expansion card configured to serveas a communication router for devices it is in wireless communicationwith. Other variations exist, and a particular implementation of acommunication hub (20) and available features will depend upon suchfactors as desired cost, setting, use, and other factors.

B. Exemplary Communication Hub Overview

FIG. 38 shows a set of exemplary steps that may be performed bycommunication hub (20). As noted above, communication hub (20) may be incommunication with sterilizing cabinet (100, 150) via communicationmodule (164). Communication hub (20) may thus receive data fromsterilizing cabinet (100, 150) (block 1100). By way of example only, andas noted above, this data may include information relating to asterilization cycle (block 210, block 504). As also noted above,communication hub (20) may be in communication with biological indicatoranalyzer (102, 800, 950) via communication module (860). Communicationhub (20) may thus receive data from biological indicator analyzer (102,800, 950). By way of example only, and as noted above, this data mayinclude information relating to passage of a biological indicatoranalysis (block 1006) or failure of a biological indicator analysis(block 1016). While communication hub (20) is shown as only being incommunication with one sterilizing cabinet (100, 150) and with onebiological indicator analyzer (102, 800), it should be understood that asingle communication hub (20) may be in communication with severalsterilizing cabinets (100, 150) and/or several biological indicatoranalyzers (102, 800).

Communication hub (20) may further process the data received fromsterilizing cabinet (100, 150) and biological indicator analyzer (102,800, 950) by correlating the data (block 1104). By way of example only,when communication hub (20) receives a notification from biologicalindicator analyzer (102, 800, 950) that a particular biologicalindicator (700) failed a biological indicator analysis (block 1016),regardless of whether this information is pushed to communication hub(20) or pulled by communication hub (20), communication hub (20) maycorrelate the identity of that particular biological indicator (700)with a particular sterilizing cabinet (100, 150). Communication hub (20)may further correlate the identity of that particular biologicalindicator (700) with particular sterilization cycles performed by thatparticular sterilizing cabinet (100, 150, 950). With this correlatedinformation, communication hub (20) may identify sterilization cycleswhose success may be questionable, such that the sterility of themedical devices that were purportedly sterilized during suchsterilization cycles is also questionable.

Having identified sterilization cycles whose success may bequestionable, and thus medical devices whose sterility may bequestionable, communication hub (20) may automatically send outnotifications to various other devices in order to prevent such medicaldevices from being used before being put through another sterilizationprocess. By way of example only, communication hub (20) may push anotification to sterilizing cabinet (100, 150) (block 1106) indicatingthe sterilization cycles whose success may be questionable, and thusmedical devices whose sterility may be questionable. Sterilizing cabinet(100, 150) may relay this notification to a user by presenting thescreen of FIG. 17 (described above) via touch screen display (160).

In addition or in the alternative, communication hub (20) may push anotification to server (106) (block 1108) indicating the sterilizationcycles whose success may be questionable, and thus medical devices whosesterility may be questionable. Of course, communication hub (20) mayalso push a notification to server (106) indicating when a biologicalindicator (700) passed analysis (block 1000) and/or other informationassociated with operation of sterilizing cabinet (100, 150) and/orbiological indicator analyzer (102, 800, 950).

In addition or in the alternative, communication hub (20) may push anotification to one or more mobile devices (block 1110), such as anoperator of system (10), etc., indicating the sterilization cycles whosesuccess may be questionable, and thus medical devices whose sterilitymay be questionable. In some versions, communication hub (20) pushessuch notifications to a mobile device associated with a person who wasidentified as a user of sterilizing cabinet (100, 150) and/or a personwho was identified as a user of biological indicator analyzer (102, 800,950) (e.g., during the user identification step (block 906)). Of course,communication hub (20) may also push a notification to one or moremobile devices indicating when a biological indicator (700) passedanalysis (block 1000) and/or other information associated with operationof sterilizing cabinet (100, 150) and/or biological indicator analyzer(102, 800, 950).

Other suitable ways in which communication hub (20) may pushnotifications to other devices will be apparent to those of ordinaryskill in the art in view of the teachings herein.

It should also be understood that communication hub (20) may be used toprovide software updates, firmware updates, and other information tosterilizing cabinet (100, 150) and/or biological indicator analyzer(102, 800, 950). As another merely illustrative example, communicationhub (20) may be used to provide hospital policy information tosterilizing cabinet (100, 150), such as hospital policy relating to thefrequency of use of biological indicators (700). Other suitable ways inwhich communication hub (20) may be used will be apparent to those ofordinary skill in the art in view of the teachings herein.

C. Exemplary Communication Hub Methods and Interfaces

FIG. 41 shows an exemplary set of steps that may be performed using acommunication hub (20) such as that shown in FIG. 39-40 to manageconnections between the communication hub (20) and one or moreprocessing components (100, 102, 104, 150, 800). These steps may beperformed at various times, such as when a new processing component(100, 102, 104, 150, 800) is created and configured for thecommunication hub (20), or when an existing processing component (100,102, 104, 150, 800) has been moved to a new physical location or a newnetwork location.

A connection request may be received (block 1300) by the communicationhub (20) from a user device (108). The connection request may identify acomponent (100, 102, 104, 150, 800) for which network communicationneeds to be established, or may identify a component (100, 102, 104,150, 800) for which network communication has previously beenestablished that needs to be modified or re-established. Thecommunication hub (20) may identify the component (100, 102, 104, 150,800) type based upon the received (block 1300) request, and display(block 1302) connection instructions and input options that are specificto that component (100, 102, 104, 150, 800) via a display (1606) of theuser device (108). Information provided by a user in response to theconnection instructions may be received (block 1304) by thecommunication hub (20) and used to attempt (block 1306) to establish anetwork connection between the communication hub (20) and the component(100, 102, 104, 150, 800).

If this network connection is successful, as may be indicated by asuccessful network ping, packet exchange, or other transmission ofinformation, a success message may be displayed (block 1310) indicatingthat the component (100, 102, 104, 150, 800) connection was successful.If the network connection was not successful, perhaps due to user erroror a network issue, a connection failure message may be displayed (block1312) and the user may be returned to a step where the connectioninstructions are displayed (block 1302) so that further attempts may bemade.

FIGS. 59-60 show several examples of interfaces that may be displayed toa user as part of the steps of FIG. 41 . It should be understood thatthe interfaces of FIGS. 59-60 may be shown on a display of user device(108). In addition, or in the alternative, in cases where communicationhub (20) has its own display (1606), the interfaces of FIGS. 59-60 maybe shown on display (1606) of communication hub (20).

FIG. 59 shows an example of an interface that may be displayed to a userwhen displaying (block 1302) connection instructions (1501, 1504) to auser. Such an interface may also have a network identifier (1502) wherea unique identifier for a device may be provided, which may include anIP address, a MAC address, a proprietary addressing identifier, or otheridentifier. Also included may be an interface element that may beinteracted with in order to test a connection (1500) before submittingthe connection information. Interacting with a test connection (1500)tool may cause the communication hub (20) to send a test ping, packet,or communication to the identified device (1502) and report whether itwas successfully received. An interface may be displayed to a user whendisplaying (block 1310) connection success after a successful (block1308) device connection attempt (block 1306).

FIG. 60 shows an alternate exemplary interface that may be used todisplay (block 1302) connection instructions to a user. The interface ofFIG. 60 shows additional features that a device connection interface mayhave, such as a dynamically generated code (1506) that may be generatedby either the communication hub (20) or the connecting component (100,102, 104, 150, 800), and then provided to the other component (100, 102,104, 150, 800) which may use the code to locate and connect to thecomponent (100, 102, 104, 150, 800) via the network. For example, insome versions, the communication hub (20) is configured to generate aconnection code by interacting with an interface element (1508) to causea connection code (1506) to be displayed. The connection code (1506) maythen be entered via an interface of the target component (100, 102, 104,150, 800), such as a sterilizing cabinet (100) or indicator analyzer(102) keyboard or touch screen, which is able to determine thecommunication hub (20) network identity and location based upon thecode. The target component (100, 102, 104, 150, 800) may send a testcommunication to the communication hub (20) that, when received, may beused by the communication hub (20) to identify the network identity andlocation of the target device.

An alternate exemplary interface may be used to display (block 1302)connection instructions to a user, as well as a username and passwordrequirement that may be required in addition to identifying the targetcomponent (100, 102, 104, 150, 800), which may be useful when connectingto devices (100, 102, 104, 150, 800) that store sensitive medicalinformation and which must be protected with some level ofauthentication. Other alternate examples of interfaces may be used todisplay (block 1310) a success message after a successful (block 1308)connection attempt (block 1306).

In addition to using generated codes that may be decrypted orinterpreted in order to identify a component (100, 102, 104, 150, 800)within a network for connection and unique identifiers such as IPaddress or MAC address, other methods exist that may be used to helpconnect or pair devices (100, 102, 104, 150, 800) with communication hub(20). For example, using an alternate input (1614) such as a barcode orQR code scanner, or a mobile device camera configured to capture animage of a barcode or QR code, or a wireless technology such as NFC orRFID, device connection may be completed between a communication hub(20) and a target component (100, 102, 104, 150, 800). For example, oneor both devices (100, 102, 104, 150, 800) could have or display aphysical tag with a visual identifier or a wireless tag with a uniqueidentifier, and such information may be captured by a user device (108)with an alternate input (1614) and used to complete the connection. Thiscould also include, for example, a sterilizing cabinet (100) having a QRcode or NFC tag that, when scanned, automatically populates and submitsnetwork identifier information to complete the connection. Such a tagcould be physically placed on the equipment, or could be displayed via adisplay of the equipment, or transmitted via a wireless communicationtransmitter of the equipment. Such a machine readable code, once read,could provide the information needed to complete the connection, orcould provide instructions to retrieve the needed information fromanother location on the network such as a network identity server, whichmay contain one or more records identifying various devices on thenetwork and what their current network location is. Variations on thesteps and interfaces shown and discussed in relation to FIG. 41 exist,and will be apparent to those of ordinary skill in the art in light ofthe disclosure herein.

FIG. 42 shows an exemplary set of steps that may be performed using acommunication hub (20) such as that shown in FIGS. 39-40 to manage oneor more processing components (100, 102, 104, 150, 800). Initially, thecommunication hub (20) may receive (block 1620) a user's logininformation such as password and username from a user device (108).While not required, a user login may provide additional security thatmay be desirable before allowing a user to access a system that displaysmedical records and information. One or more sites may also be displayedto a user, and a site selection received (block 1622) identifying aparticular site or sites that a user wishes to monitor and manageprocessing components (100, 102, 104, 150, 800) at. A site may be ageographical location such as a hospital, or may be a particularlocation within a hospital, such that a hospital may have a single siteor multiple sites. A site may have one or more communication hubs (20)providing connectivity and monitoring of processing components (100,102, 104, 150, 800) at that site.

Once a site is specified, one or more devices (100, 102, 104, 150, 800)may be displayed to a user, and a component (100, 102, 104, 150, 800)selection may be received (block 1624) identifying a particularcomponent (100, 102, 104, 150, 800) or devices (100, 102, 104, 150, 800)that the user wishes to monitor or manage. Once one or more devices(100, 102, 104, 150, 800) have been selected to view or manage, thecommunication hub (20) may receive (block 1626) user input from the userdevice (108) requesting summary information (block 1628) for a device ordevices, task details (block 1632) for one or more tasks presently orpreviously performed on a component (100, 102, 104, 150, 800), or anactivity graph (block 1636) or other visualization of tasks presently orpreviously performed on a component (100, 102, 104, 150, 800). Inresponse to received (block 1626) requests, the communication hub (20)may transmit information to the user device (108) configured to causethe user device (108) to display (block 1630) an overview of taskinformation for one or more devices (100, 102, 104, 150, 800), display(block 1634) detailed information for a task, or display (block 1638) avisualization of task information for a component (100, 102, 104, 150,800).

FIGS. 45-57 show several examples of interfaces that may be displayed toa user during one or more of the steps shown in FIG. 42 . A hospitalsite selection interface may be displayed as part of displaying andreceiving (block 1622) a hospital site selection from a user. FIG. 45shows a component (100, 102, 104, 150, 800) selection interface that maybe displayed as part of displaying a receiving a device selection from auser. While the interface of FIG. 45 shows four devices (100, 102, 104,150, 800), it should be understood that any number of devices may besupported by scaling the display, individual icons, or adding additionalinterface elements to allow scrolling or page navigation of icons.

A site identifier (1402) indicates the user's site selection. A devicestatus indicator may show that the component (100, 102, 104, 150, 800)is connected to the communication hub (20), or that there is an issuewith the device connection (1410). A device icon (1406) may show avisual representation of a device to aid in selecting a component (100,102, 104, 150, 800). This may be helpful, for example, when a user isaccessing the communication hub (20) via a user device (108) such as amobile phone, and a user is physically present at a sterilizationcabinet (100) and wishes to monitor and manage its performance. Such avisual icon (1406) may aid the user in identifying the correct component(100, 102, 104, 150, 800) to view and manage. Additional device specificstatus indicators may also be shown, such as a biological indicator well(810) status for an indicator analyzer (102, 800), which may showwhether a particular indicator well (810) is currently in use (1408) oropen for use (1409). Such a feature may allow a clinician that needs toanalyze an indicator to identify and locate an indicator analyzer (102,800) that has currently available well (810) capacity using a mobileuser device (108) rather than by physically locating the indicatoranalyzer (102, 800) and visually confirming whether or not a well (810)is available.

FIG. 46 shows an interface that may be displayed to a user as part ofdisplaying (block 1630) a task and status overview (1412) for a singlecomponent (100, 102, 104, 150, 800) to a user. Information shown mayinclude a device identifier and icon, a statistics summary (1414)showing information such as how many sterilization cycles a sterilizingcabinet (100, 150) has completed, a number of cycles run per day, and anumber of sterilization cycles in which a biological indicator has beenused. Also shown may be a table having a row for each sterilizationcycle performed, which may include columns such as a cycle identifier(1416), a cycle start time (1418), a cycle status (1420) indicatingwhether the cycle completed, failed, or was canceled, and a biologicalindicator result (1422) indicating whether an indicator was used, andwhether the indicator determined that the sterilization cycle was asuccess or a failure. Also present on such an interface may sorting orfiltering options, allowing a table to be sorted according to one ormore of the columns, a date range selection (1424) allowing cyclespresent in the table to be restricted to a certain date range, and acycle search (1426) allowing for a particular cycle number, date,status, or indicator result to be searched for.

FIG. 47 shows an interface similar to that of FIG. 46 , where theresults of a particular task have been expanded to show additionalinformation (1430) relating to that cycle, which may include, forexample, cycle type, load conditioning, cycle operator, start time,indicator result, and indicator operator. FIG. 47 may be shown as partof displaying (block 1634) task detail for a particular task or cycle.FIG. 48 shows an additional interface that may be displayed to a user aspart of displaying (block 1634) task detail for a particular task. Aninterface such as that of FIG. 48 may show such information as a cycleinformation window (1432) having such information as cycle status,device identifier, cycle identifier, cycle type, load conditioning,cycle operator, cycle date, start time, end time, duration of cycle,facility name, department name, sterilization cassette lot number,biological indicator status, and manually entered cycle notes.Information shown may also include a biological indicator window (1434),that may show such information as indicator result, indicator readerused, indicator type, indicator lot number, indicator serial number,indicator expiration date, indicator operator, indicator entry time,indicator entry date, indicator result time, indicator color change, andincubation temperature.

Another exemplary interface may be shown as part of displaying (block1634) task detail for a particular cycle or device, which may includeinformation such as maximum and minimum values for various physicalattributes of sterilizing cabinet (100, 150) such as chamber, vapor, andconditioning pressure and temperature, delivered power, plasma time, andother attributes.

FIG. 49 shows an interface that may be shown as part of displaying(block 1638) a task or activity graph selection for a selected component(100, 102, 104, 150, 800). In such an interface, some icons may be solid(1436) indicating that they are available for the selected component(100, 102, 104, 150, 800); while others may be greyed out orsemi-translucent (1454) indicating that they are unavailable for theselected component (100, 102, 104, 150, 800). For example, one type ofsterilizing cabinet (100) may generate information during asterilization cycle which can be viewed in an H2O2 graph (1436), but maynot generate information which can be viewed in a door temperature graph(1454). FIG. 55 shows an interface that may be displayed for a differenttype of sterilizing cabinet (100), which supports some additionalvisualization options such a load conditioning temperature graph (1456).

Visualizations options may vary depending upon the particular deviceselected, but may include information relating to the device or a cycleof the device as a short printable view, medium printable view, longprintable view, parametric format view, door temperature graph,sterilization chamber graph, vapor temperature graph, conditioningtemperature graph, chamber pressure graph, vapor pressure graph, H202graph, plasma graph, partial or complete one second data file, alarmlimit report view, indicator data file, indicator printable view,indicator graphs, indicator long printable view, and other views andvisualizations that may be desirable.

FIG. 50 shows an interface that may be shown as part of displaying(block 1638) a task or activity graph for a component (100, 102, 104,150, 800). A graph type selection (1438) may be interacted with by auser to select to see information graphed as, for example, a 30-daycycle breakdown, a 7-day cycle breakdown, a 30-day cycle cancellationrate, a 30-day cycle count, a 30-day biological indicator usage, andother graphs as may be desirable for a sterilizing cabinet (100) orindicator analyzer (102). Also included may be a graphical visualization(1440) such as a chart, graph, table, or other data model that mayinclude one or more visible data indicators such as size, shape, color,numbers, and arrangement, and a visualization key (1442) providingfurther explanation for graphical visualization (1440) including anindication of what visible data indicators represent.

FIG. 51 shows an interface similar to that of FIG. 50 , which may beshown after a user has selected to view a different cycle breakdown,such as the 7-day cycle breakdown instead of the 30-day cycle breakdown.FIG. 52 shows an interface similar to that of FIG. 50 , which may beshown after a user has selected to view a cycle cancellation rate, andwhich may include a cancellation graph (1444) or other visualizationshowing a number of percentage of cycles which have been canceled orotherwise failed over the selected time period. FIG. 53 shows aninterface similar to that of FIG. 50 , which visualizes data as a barchart (1446) instead of a pie chart. FIG. 54 shows an interface to thatof FIG. 53 , which visualizes data as a bar chart (1448) including twovariables, one for cycles in which a biological indicator was used, andone for cycles which did not use a biological indicator.

FIG. 56 shows an interface that may be shown as part of displaying(block 1630) a task or device overview or summary which shows additionalstatus information for the selected device. FIG. 56 shows a statusoverview for an indicator analyzer (102, 800) that indicates whethereach indicator well (810) is in use or not. While FIG. 56 shows suchfeatures specific to a biological indicator, it should be apparent thatsuch principles may also be applied to other processing components (100,102, 104, 150, 800) such as a sterilizing cabinet (100). An interfacesuch as that shown in FIG. 56 may include an indicator well identifier(1458), an indicator well progress indicator (1460), an indicator welltype (1462) and result for a selected indicator well (810), an indicatorwell vacant indicator (1464), and other information that may begenerated by the indicator analyzer (102, 800) and displayed on a statusoverview interface. Similar information may be shown for a sterilizationcabinet (100, 150), such as how many chambers (152) the cabinet (100,150) has, which chambers (152) are in use, what their currenttemperature or pressure is, a remaining time for a currently performedcycle, and other information that may be generated by a sterilizingcabinet (100, 150) and displayed on a status overview interface.

Another interface may show a table of task details for an indicatoranalyzer (102, 800). Shown information may include an analysis starttime, biological indicator type, biological indicator status,sterilization cycle number, sterilization cycle type, and sterilizationcycle status. Also shown may be an indicator well status that indicatesthe status of each indicator well (810) of an indicator analyzer (102,800). FIG. 57 shows an interface which may be shown when a user selectsa particular task from the table in order to see additional informationfor that task or indicator analysis.

Another interface may be shown when a user selects to see a complete setof information for an indicator task and any related sterilization cycletask (1432). This interface may display information including but notlimited to whether the biological indicator passed the analysis, theidentity of the indicator analyzer (102, 800), the type of biologicalindicator, the lot number of the biological indicator, the serial numberof the biological indicator, the expiration date of the biologicalindicator, the date and time of the biological indicator analysis, theidentity of the operator who initiated the biological indicatoranalysis, the temperature at which the biological indicator analysis wascarried out, the identity of the sterilizing cabinet (100, 150) in whichthe biological indicator encountered a sterilization cycle, theassociated sterilization cycle number, the type of associatedsterilization cycle, the identity of the operator of the associatedsterilizing cabinet (100, 150), the time and location of the associatedsterilization cycle, etc.

Another interface may be shown as part of displaying (block 1630) a taskor device overview, specifically, when there is a history ofnotifications for the task or component (100, 102, 104, 150, 800). Suchan interface may show a notification table having a notification type,which may include notification types such as cancelled cycle, failed(positive) biological indicator, passed (negative) biological indicator,and other notifications. Such a table may additionally show a detailscolumn which may provide details relating to the notification, such asany error messages or status reports generated as part of thenotification.

Another interface may be shown as part of displaying (block 1630) a taskor device overview, specifically, when there may be user entered notesassociated with the component (100, 102, 104, 150, 800) or task.Information shown may include a date of note entry, note author, andnote text. An interface may be shown as part of displaying (block 1630)a task or device overview for an indicator analyzer (102) that includesinformation on biological indicator lots. Information shown may includea lot identifier, a control result for that lot, a previous control endtime, and a number of controls performed for that lot. Such an interfacemay be helpful in providing information to a user to identify biologicalindicator lots from which to select an indicator for a test, and mayalso aid in selecting an indicator from a let for a control so thatothers may use indicators from that lot for tests.

FIG. 43 shows an exemplary set of steps that may be performed using acommunication hub (20) such as that shown in FIGS. 39-40 to manageconfigurations of a network of processing components (100, 102, 104,150, 800). After a login attempt is received (block 1620) and validated,one or more configuration selections may be received (block 1640) from auser of the user device (108). Received configuration selections mayinclude selections to manage devices (block 1642) that are configured tobe monitored or managed by the communication hub (20), selections tomanage users (block 1644) that are configured to access or interact withthe communication hub (20), selections to manage notification settings(block 1646), settings to manage sites that are monitored and managed bythe communication hub (20), and other similar configurations. Managingdevices (block 1642) may include adding, removing, or modifyingconfigured devices (100, 102, 104, 150, 800), and may also includeconnecting to devices (100, 102, 104, 150, 800) over a network asdescribed in FIG. 41 . Managing users (block 1644) may include adding,removing, or modifying users. Managing notifications may includeconfiguring and modifying notification settings, such as determiningwhich users will receive certain notification types and over what methodof communication they will be received. Managing sites may includeadding, removing, or modifying sites, and determining what users anddevices (100, 102, 104, 150, 800) are associated with sites.

Another interface may be shown when a user manages devices (block 1642).Information shown may include a table having one or more of a deviceidentifier, a device category, a device department, and a deviceconnection status. FIG. 58 shows an interface that may be shown when auser manages devices (block 1642) and selects a particular component(100, 102, 104, 150, 800) to manage, modify, or review. Showninformation may include additional device information (1498) such asserial number, model number, software version, firmware version, andcycle types or other tasks supported by the component (100, 102, 104,150, 800). Another interface may be shown when a user selects to modifya component (100, 102, 104, 150, 800). Information that is displayed andmodifiable by a user interacting with such an interface may includedevice identifier, device category, device model, cycle types, tasks, orother features supported by the device, deice department, serial number,software version, firmware version, and language.

Another interface may be shown when a user selects to disable acomponent (100, 102, 104, 150, 800) during device management (block1642), requesting the user to explicitly confirm their intent to disablecomponent (100, 102, 104, 150, 800). Another interface may also be shownwhen a user selects to add a component (100, 102, 104, 150, 800) duringdevice management (block 1642). Information that is shown and modifiableby a user when adding a component (100, 102, 104, 150, 800) may includedevice identification, device category, device model, cycle, tasks, orfeatures supported by the device, department, serial number, softwareversion, firmware version, and device language. One or more pieces ofdevice information may be automatically populated or updated byconnecting the communication hub (20) to a component (100, 102, 104,150, 800), which may then provide information over the network. Anotherinterface may be shown to a user during device management (block 1642)when a component (100, 102, 104, 150, 800) is created but not yetconnected to the communication hub (20), which may allow a user toproceed to the steps of FIG. 41 and the interfaces of FIGS. 59-60 with asingle interaction.

Another interface may be shown to a user as part of user management(block 1644). Such an interface may show and allow modifications to auser information table (1510) that may include such information as firstand last names of users, user types, usernames, and email addresses forone or more users that have been configured within the system.

Another interface may be shown to a user as part of site management(block 1648). Such an interface may show and allow modifications to asite information table (1512) that may include such information ascustomer identifier, site name, country, states, and city. An interfacemay be shown to a user as part of site management (block 1648). Such aninterface may show information on one or more sites, and allow a user toselect sites (1514) to activate or deactivate. An interface may be shownto a user as part of site management (block 1648) when a user selects toadd a new site. Information that is shown and modifiable by a user mayinclude customer identifier, site name, stress address, city, state,country, zip code, global region, cluster, biomed, phone number, andprimary, secondary, and tertiary FSE.

Another interface may be shown to a user as part of notificationmanagement (block 1646). Such an interface may show a notificationconfiguration window (1516) which allows a user to select, for eachnotification type, whether notifications should be generated through oneor more communication types such as email, SMS, web portal, phone, orother similar communications. Another interface may be shown to a useras part of notification management (block 1646) when a user selects toview a summary of many notifications for a particular site orcommunication hub (20). Such an interface may show notifications from avariety of devices (100, 102, 104, 150, 800) for that site or hub (20),and information may include notification type and description (1518),origin device identifier (1520), and date and time of notificationreceipt (1522).

Another interface may be shown to a user as part of notificationmanagement (block 1646) when a user selects to view additionalinformation for a single notification. Such additional information mayinclude, for example, indicator test result, indicator test type, lotnumber, time indicator added, device identifier, cycle type, cycleidentifier, cycle start time, and cycle end time. Additional informationshown may include, for example, device last connection time, device lastconnection site, device current connection status, and other similarinformation

FIG. 44 shows an exemplary set of steps that may be performed using acommunication hub (20) such as that shown in FIG. 39-40 to managecommunications between devices (100, 102, 104, 150, 800) of a network ofprocessing components (100, 102, 104, 150, 800). In some cases, devicespresent in a network of processing components (100, 102, 104, 150, 800)may exchange information with each other through communication hub (20).As has been disclosed above in some detail, this may include situationswhere an indicator analyzer (102) or sterilizing cabinet (100) generatesinformation which is passed to communication hub (20) and then accessedand displayed on a user device (108). However, this could also include asterilizing cabinet (100) generating a record of a sterilization cycle,and transmitting that record to an indicator analyzer (102) so that abiological indicator analysis performed on the analyzer (102) may beassociated with a sterilization cycle performed on the sterilizingcabinet (100). This could also include information generated by one ormore devices (100, 102, 108, 150, 800) being transmitted to server (106)via the communication hub (20), such as medical records being generatedat a device (100, 102, 108, 150, 800) and then sent to a server (106)for long term medical record storage. This could also include theopposite, such as software updates, firmware updates, userconfigurations, site configurations, device configurations, and otherinformation being prepared on server (106) and distributed to one ormore devices (100, 102, 108, 150, 800) where they can be used to updatesoftware, firmware, or configurations. Other communications andcommunication types enabled by a communication hub (20) connecting oneor more processing components (100, 102, 104, 150, 800) will be apparentto those of ordinary skill in the art in light of the disclosure herein.

When a communication is received (block 1650) by the hub (20), it may bedetermined (block 1652) what the communications destination is basedupon the type, form, or contents of data included in the communication.For example, if hub (20) receives a software patch bundled with dataindicating it is intended for sterilization cabinets (100), the hub (20)will be able to determine the destination for the software patch. Thehub (20) may also identify (block 1654) one or more destinations withinits network. Following the above example, this could include identifyingeach sterilization cabinet (100, 150) that the hub (20) is connected toacross one or more configured sites. The hub (20) may also prepare(block 1656) or modify the data in order to prepare it for transmissionto the destination. This could include changing the form of thecommunication to a format that is expected or acceptable by thedestination device, could include removing unnecessary information fromthe communication, such as destination identifying information which mayno longer be necessary, could include encrypting the information,pairing it with authentication information, or modifying it in otherways to ensure security of the transmission to the destination, andother types of data preparation activities. The hub (20) may also thentransmit data to one or more destinations depending upon whether thedestination has been identified as a sterilizing cabinet (block 1658,100), indicator analyzer (block 1662, 102), or another device (block1666) such as a user device (108) or server (106).

If the destination is identified as one or more sterilizing cabinets(block 1658), the hub (20) may transmit the prepared data to thedestination where it may be received and used to update software, updatefirmware, display a message via a display of the cabinet (100, 150),update one or more records stored locally on the cabinet (100, 150) suchas user configurations or device configurations, or similar actions. Incases where data is sent to a sterilizing cabinet (block 1660), it mayalso be sent to a server (106) where a remote record of the data may bemaintained (block 1670) in case of data loss or device failure.Similarly, if the target destination is determined to be one or moreindicator analyzers (block 1662) or other device (block 1666), theprepared data may be sent to the analyzer (block 1664) or other device(block 1668) and also maintained as a remote record (block 1670).

VII. Exemplary Medical Device Reprocessor

Reprocessor (104) of the present example is configured to reprocess(i.e., decontaminate) medical devices (e.g., used or otherwisenon-sterile medical devices) such as endoscopes. In particular,reprocessor (104) is configured to enclose an endoscope in a sealedchamber; flush the internal lumen(s) of the endoscope with detergent,water, alcohol, and/or various other liquids; spray the exterior of theendoscope with detergent, water, alcohol, and/or various other liquids;and dry the interior and exterior of the endoscope. In some instances,while the endoscope has not necessarily been sterilized, the endoscopemay nevertheless be ready for use in another medical procedure afterhaving been reprocessed through reprocessor (104).

By way of example only, reprocessor (104) may be configured and operablein accordance with at least some of the teachings of U.S. Pat. No.6,986,736, entitled “Automated Endoscope Reprocessor Connection withIntegrity Testing,” issued Jan. 17, 2006, the disclosure of which isincorporated by reference herein; U.S. Pat. No. 7,479,257, entitled“Automated Endoscope Reprocessor Solution Testing,” issued Jan. 20,2009, the disclosure of which is incorporated by reference herein; U.S.Pat. No. 7,686,761, entitled “Method of Detecting Proper Connection ofan Endoscope to an Endoscope Reprocessor,” issued Mar. 30, 2010, thedisclosure of which is incorporated by reference herein; U.S. Pat. No.8,246,909, entitled “Automated Endoscope Reprocessor GermicideConcentration Monitoring System and Method,” issued Aug. 21, 2012, thedisclosure of which is incorporated by reference herein; and/or U.S.patent application Ser. No. 15/157,800, entitled “Apparatus and Methodfor Reprocessing a Medical Device,” filed May 20, 2016, the disclosureof which is incorporated by reference herein. An example of acommercially available reprocessor (104) is the EVOTECH® EndoscopeCleaner and Reprocessor (ECR) by Advanced Sterilization Products ofIrvine, California. Other suitable ways in which reprocessor (104) maybe configured and operable will be apparent to those of ordinary skillin the art in view of the teachings herein.

It should also be understood that some medical devices (e.g.,endoscopes) may be processed in reprocessor (104) without also beingprocessed in sterilizing cabinet (100, 150). Likewise, some medicaldevices (e.g., endoscopes) may be processed in sterilizing cabinet (100,150) without also being processed in reprocessor (104). The decision onwhether to process a medical device such as an endoscope throughsterilizing cabinet (100, 150) or reprocessor (104) may be based on thekind of endoscope at hand and/or based on the location(s) within thepatient anatomy in which the endoscope is typically used.

VIII. Exemplary User Device

User device (108) may comprise a device such as a laptop computer, adesktop computer, a mobile device such as a smartphone, tablet, or othermobile computing device, or a proprietary device having similarcapabilities, such capabilities including wired or wirelesscommunication with devices such as communication hub (20), a processorand memory, a display, a user interface, and other capabilities as maybe described in further detail below. User device (108) may be used toaccess and view information associated with one or more processingcomponents (100, 102, 104, 150, 800) via communication hub (20), and mayalso be used to create or modify configurations and settings ofcommunication hub (20) and connected devices. A user of user device(108) may view information and configure devices via, for example, adesktop software application, a mobile device software application, aweb browser, or another software interface that may allow user device(108) to exchange information with communication hub (20). While onlyone user device (108) is shown in FIG. 1 and in FIG. 39 as being incommunication with communication hub (20), it should be understood thatseveral user devices (108) may be in communication with communicationhub (20). Similarly, several sterilizing cabinets (100), severalbiological indicator analyzers (102), and/or several servers (106) maybe in communication with communication hub (20).

IX. Exemplary Combinations

The following examples relate to various non-exhaustive ways in whichthe teachings herein may be combined or applied. It should be understoodthat the following examples are not intended to restrict the coverage ofany claims that may be presented at any time in this application or insubsequent filings of this application. No disclaimer is intended. Thefollowing examples are being provided for nothing more than merelyillustrative purposes. It is contemplated that the various teachingsherein may be arranged and applied in numerous other ways. It is alsocontemplated that some variations may omit certain features referred toin the below examples. Therefore, none of the aspects or featuresreferred to below should be deemed critical unless otherwise explicitlyindicated as such at a later date by the inventors or by a successor ininterest to the inventors. If any claims are presented in thisapplication or in subsequent filings related to this application thatinclude additional features beyond those referred to below, thoseadditional features shall not be presumed to have been added for anyreason relating to patentability.

Example 1

A system comprising: (a) a sterilizing cabinet, wherein the sterilizingcabinet includes a sterilization chamber, wherein the sterilizingcabinet is operable to sterilize a medical device disposed in thesterilization chamber; (b) a biological indicator analyzer, wherein thebiological indicator analyzer is operable to detect the presence of aliving organism in a biological indicator assembly; and (c) acommunication hub, wherein the sterilizing cabinet is in communicationwith the communication hub, wherein the biological indicator analyzer isalso in communication with the communication hub, wherein thecommunication hub is operable to transmit information from thebiological indicator analyzer to the sterilizing cabinet.

Example 2

The system of Example 1, further comprising a server, wherein the serveris in communication with the communication hub.

Example 3

The system of Example 2, wherein the communication hub is operable totransmit information from the biological indicator analyzer to theserver.

Example 4

The system of any one or more of Examples 2 through 3, wherein thecommunication hub is operable to transmit information from thesterilizing cabinet to the server.

Example 5

The system of any one or more of Examples 2 through 4, wherein thecommunication hub is operable to transmit information from the server tothe sterilizing cabinet.

Example 6

The system of any one or more of Examples 2 through 4, wherein thecommunication hub is operable to transmit information from the server tothe biological indicator analyzer.

Example 7

A sterilizing cabinet, wherein the sterilizing cabinet includes asterilization chamber, wherein the sterilizing cabinet is operable tosterilize a medical device disposed in the sterilization chamber,wherein the sterilizing cabinet is further operable to condition themedical device before sterilizing the medical device.

Example 8

The sterilizing cabinet of Example 7, wherein the sterilizing cabinet isoperable to condition the medical device before sterilizing the medicaldevice by detecting moisture on the medical device and removing themoisture from the medical device.

Example 9

A sterilizing cabinet, comprising: (a) a sterilization chamber, whereinthe sterilizing cabinet is operable to sterilize a medical devicedisposed in the sterilization chamber; and (b) a reader, wherein thereader is operable read an identification tag of a biological indicator.

Example 10

The sterilizing cabinet of Example 9, wherein the reader is operable toscan an optical code on the biological indicator.

Example 11

The sterilizing cabinet of any one or more of Examples 9 through 10,further comprising a graphical user interface, wherein the graphicaluser interface is configured to prompt a user to operate the reader toread an identification tag of a biological indicator.

Example 12

The sterilizing cabinet of Example 11, wherein the graphical userinterface is further configured to prompt a user to select asterilization cycle from a plurality of available sterilization cycles.

Example 13

The sterilizing cabinet of Example 12, wherein the sterilizing cabinetis configured to identify a particular kind of biological indicatorassociated with a particular sterilization cycle selected by the user,wherein the graphical user interface is further configured to prompt auser to operate the reader to read an identification tag of theparticular kind of biological indicator associated with a particularsterilization cycle selected by the user.

Example 14

A method of processing a medical device, the method comprising: (a)receiving input from a user selecting a particular sterilization cyclefrom a plurality of available sterilization cycles; (b) identifying aparticular kind of biological indicator associated with the selectedsterilization cycle; (c) prompting the user to place the medical deviceand the identified biological indicator into a sterilization chamber ofa sterilizing cabinet; (d) performing load conditioning on the medicaldevice in the sterilization chamber, wherein the act of performing loadconditioning comprises removing moisture from the medical device; and(e) performing the selected sterilization cycle on the medical device inthe sterilization chamber after completing the act of load conditioning.

Example 15

The method of Example 14, further comprising prompting the user to scanan identification tag of the identified biological indicator beforeprompting the user to place the medical device and the identifiedbiological indicator into the sterilization chamber.

Example 16

The method of Example 15, further comprising evaluating a facilitypolicy regarding use of biological indicators, wherein the act ofprompting the user to scan an identification tag of the identifiedbiological indicator is performed based on the evaluation of thefacility policy regarding the user of biological indicators.

Example 17

The method of any one or more of Examples 15 through 16, wherein thesterilizing cabinet has a graphical user interface, wherein the act ofprompting the user to scan an identification tag of the identifiedbiological indicator is performed through the graphical user interface.

Example 18

The method of any one or more of Examples 14 through 17, wherein thesterilizing cabinet has a touch screen.

Example 19

The method of Example 18, wherein the input from the user selecting theparticular sterilization cycle is received via the touch screen.

Example 20

The method of any one or more of Examples 18 through 19, wherein the actof prompting the user to place the medical device and the identifiedbiological indicator into a sterilization chamber of a sterilizingcabinet is performed via the touch screen.

Example 21

The method of any one or more of Examples 18 through 20, furthercomprising presenting the user with information regarding each of theavailable sterilization cycles via the touch screen.

Example 22

The method of any one or more of Examples 18 through 21, furthercomprising presenting the user with information regarding the completedsterilization cycle after performing the selected sterilization cycle onthe medical device, wherein the act of presenting the user withinformation regarding the completed sterilization cycle is performed viathe touch screen.

Example 23

A method of processing a medical device, the method comprising: (a)receiving input from a user selecting a particular sterilization cyclefrom a plurality of available sterilization cycles; (b) identifying aparticular kind of biological indicator associated with the selectedsterilization cycle; (c) prompting the user to use a reader of asterilizing cabinet to read an identification tag of the identified kindof biological indicator; (d) receiving information from the reader basedon the user's use of the reader to read an identification tag of abiological indicator; (e) prompting the user to place the medical deviceand the identified biological indicator into a sterilization chamber ofthe sterilizing cabinet; and (f) performing the selected sterilizationcycle on the medical device in the sterilization chamber.

Example 24

The method of Example 23, further comprising performing loadconditioning on the medical device in the sterilization chamber, whereinthe act of performing load conditioning comprises removing moisture fromthe medical device.

Example 25

The method of Example 24, wherein the act of performing the selectedsterilization cycle is performed after completing the act of loadconditioning.

Example 26

The method of any one or more of Examples 23 through 25, furthercomprising determining whether the information received from the readerindicates that the user has selected the particular kind of biologicalindicator associated with the selected sterilization cycle.

Example 27

The method of Example 26, wherein the act of determining indicates thatthe user has not selected the particular kind of biological indicatorassociated with the selected sterilization cycle, the method furthercomprising informing the user that the user has not selected theparticular kind of biological indicator associated with the selectedsterilization cycle.

Example 28

A method of processing a medical device, the method comprising: (a)receiving input from a user selecting a particular sterilization cyclefrom a plurality of available sterilization cycles; (b) identifying aparticular kind of biological indicator associated with the selectedsterilization cycle; (c) prompting the user to place the medical deviceand the identified biological indicator into a sterilization chamber ofthe sterilizing cabinet; (d) performing the selected sterilization cycleon the medical device in the sterilization chamber; and (e) determiningwhether the identified biological indicator contains any livingorganisms after performing the selected sterilization cycle.

Example 29

The method of Example 28, wherein the act of determining whether theidentified biological indicator contains any living organisms comprisesevaluating fluorescence associated with the identified biologicalindicator.

Example 30

The method of any one or more of Examples 28 through 29, wherein the actof determining whether the identified biological indicator contains anyliving organisms indicates that the identified biological indicatorcontains a living organism, the method further comprising informing theuser that the identified biological indicator contains a livingorganism.

Example 31

The method of Example 30, wherein the act of informing the user that theidentified biological indicator contains a living organism is performedvia the sterilizing cabinet.

Example 32

The method of any one or more of Examples 28 through 31, wherein the actof determining whether the identified biological indicator contains anyliving organisms is performed using a biological indicator analyzer,wherein the biological indicator analyzer is separate from thesterilizing cabinet.

Example 33

A biological indicator analyzer, comprising: (a) a plurality of wells,wherein each well is configured to receive a respective biologicalindicator; (b) a plurality of organism detector features, wherein eachorganism detector feature is configured to detect whether a biologicalindicator disposed in a corresponding well of the plurality of wellscontains a living organism; and (c) a touch screen, wherein the touchscreen is configured to receive user input and provide information tothe user indicating a status of biological indicator analysis.

Example 34

The biological indicator analyzer of Example 33, wherein the organismdetector features comprise: (i) light sources configured to emit lighttoward biological indicators disposed in the wells, and (ii) sensorsconfigured to detect fluorescence from biological indicators disposed inthe wells.

Example 35

The biological indicator analyzer of any one or more of Examples 33through 34, further comprising a communication port, wherein thecommunication port is configured to communicate results of biologicalindicator analysis to a device located remotely from the biologicalindicator analyzer.

Example 36

The biological indicator analyzer of any one or more of Examples 33through 35, further comprising a plurality of indicator sensors, whereineach indicator sensor is configured to determine whether an indicator isplaced in the well.

Example 37

The biological indicator analyzer of any one or more of Examples 33through 36, further comprising a processor and a memory, wherein theprocessor is configured to receive a well selection and an indicatorselection from a user and, in response, query a remote server todetermine whether a control indicator has been tested for an indicatorlot associated with the indicator selection and, where a controlindicator has not been tested, display a control notification to theuser via the touch screen.

Example 38

The biological indicator analyzer of Example 37, wherein the processoris further configured to detect that a control indicator has been placedin a well, incubate the control indicator, and analyze the controlindicator to determine if biological contamination is present, and,where biological contamination is present, display a notification viathe touch screen indicating that the control indicator test wassuccessful and associating the control indicator with the indicatorselection.

Example 39

The biological indicator analyzer of Example 38, wherein the processoris further configured to, where biological contamination is not presentin the control indicator, display a notification that a second controlindicator must be run from the indicator lot in a different well.

Example 40

The biological indicator analyzer of any one or more of Examples 33through 39, further comprising a processor and a memory, wherein theprocessor is further configured to, in response to receiving a signalindicating that a user intends to place an indicator in a well, displaya chemical indicator guide via the touch screen; wherein the chemicalindicator guide is configured to display an original chemical indicatorand a post-sterilization chemical indicator; wherein the processor isfurther configured to receive a selection from a user indicating whetherthe chemical indicator of the indicator matches the original chemicalindicator or the post-sterilization chemical indicator.

Example 41

The biological indicator analyzer of any one or more of Examples 33through 40, further comprising a processor and a memory, wherein theprocessor is further configured to, in response to receiving a signalindicating that a user intends to place an indicator in a well, displaya indicator activation guide via the touch screen; wherein the indicatoractivation guide is configured to display a set of instructions forbreaking a glass ampoule of the indicator, and mixing a chemicalsolution of the ampoule with the biological material; wherein theprocessor is further configured to receive a selection from a userindicating whether the glass ampoule is broken and whether the chemicalsolution has been mixed.

Example 42

The biological indicator analyzer of any one or more of Examples 33through 41, further comprising a processor and a memory, wherein theprocessor is configured to drive a display a graphical representation ofeach well via the touch screen, wherein the graphical representation isconfigured to indicate whether an indicator is present in the well, thetime remaining for a test being performed on an indicator in a well, andwhether a test being performed in a well was a success or failure.

Example 43

The biological indicator analyzer of any one or more of Examples 33through 42, further comprising a processor and a memory, wherein theprocessor is configured to, in response to a failed indicator test,receive an identification from a user of the indicator analyzer, receivean acknowledgment of the failure from the user, display a set ofquarantine instructions to the user via the touch screen, access aremote server in order to identify one or more surgical instrumentsassociated with the failed indicator, and generate a notificationcomprising a description of the one or more surgical instrumentsassociated with the failed indicator.

Example 44

A processing component network comprising: (a) a communication hubcomprising: (i) a processor, (ii) a memory, and (iii) a networkinterface; (b) a set of medical device processing components; and (c) auser device; wherein the processor is configured to execute instructionsto cause the communication hub to: (i) receive a first set of deviceconfigurations from the user device, (ii) create a device record for afirst medical device processing component of the set of medical deviceprocessing components based upon the first set of device configurations,(iii) establish a network connection to the first medical deviceprocessing component via the network interface, (iv) provide a first setof device information to the user device, wherein the first set ofdevice information is received from the first medical device processingcomponent, and (v) provide a task record to a second medical deviceprocessing component of the set of medical device processing components,wherein the task record describes a first task performed by the firstmedical device processing component; wherein the first set of deviceinformation is configured to cause the user device to display at least aportion of the first set of device information via a display of the userdevice, and wherein the task record is required by the second medicaldevice processing component in order to perform a second task.

Example 45

The processing component network of Example 44, wherein the firstmedical device processing component comprises a sterilization chamber;wherein the second medical device processing component comprises abiological indicator analyzer; wherein the first task comprises asterilization cycle performed in the sterilization chamber; and whereinthe second task comprises an analysis of a biological indicator used inthe first task.

Example 46

The processing component network of any one or more of Examples 44through 45, wherein the network interface comprises a Wi-Fi transceiver;wherein the user device is selected from the group consisting of: asmartphone, a computer, a tablet, and a laptop; wherein the first set ofdevice configurations comprises: (i) a site configuration, (ii) a deviceconfiguration, and (iii) a user configuration; wherein the first set ofdevice information comprises five or more of: (i) a cycle identifier(ii) a device identifier, (iii) a cycle status, (iv) a biologicalindicator result, (v) a number of total cycles, (vi) a number of averagecycles per day, (vii) a number of cycles including a biologicalindicator, (viii) a number of completed cycles, (ix) a number of totalindicator analyses, (x) a number of indicator analyses per day, (xi) anumber of indicators having a pass result, (xii) an indicator analyzerwell status, (xiii) a biological indicator identifier, (xiv) abiological indicator lot number, and (xv) a biological indicator colorchange.

Example 47

The processing component network of any one or more of Examples 44through 46, wherein the instructions to cause the communication hub tocreate a device record comprise instructions to: (i) determine a deviceidentifier, a device model, and a device serial number based upon thefirst set of device configurations, (ii) associate the first medicaldevice processing component with a site, wherein the site is associatedwith a geographic location, and (iii) associate a user with the site;and wherein the communication hub is further configured to only providethe first set of device information to the user device when the userdevice is associated with the user that is associated with the site.

Example 48

The processing component network of Example 47, wherein the processor isfurther configured to execute instructions to cause the communicationhub to: (i) receive a notification from the first medical deviceprocessing component, (ii) determine a set of users that are associatedwith the site, the set of users including the user, and (iii) providethe notification to a set of user devices that are associated with theset of users.

Example 49

The processing component network of any one or more of Examples 44through 48, wherein the instructions to cause the communication hub toestablish a connection to the first medical device processing componentcomprise instructions to: (i) receive a device connection request fromthe user device, (ii) provide a connection interface to the user device,(iii) receive a set of device connection information from the userdevice, the set of device connection information received via theconnection interface, and (iv) attempt a connection to the first medicaldevice processing component using the set of device connectioninformation; wherein the connection interface comprises a set ofconnection instructions.

Example 50

The processing component network of Example 49, wherein the connectioninterface is configured to receive, from the user device: (i) a networklocation identifier, a username, and a password, or (ii) a networkpairing code.

Example 51

The processing component network of any one or more of Examples 44through wherein the first medical device processing component comprisesa sterilizing cabinet, and wherein the instructions to provide the setof device information comprise instructions to provide a device overviewinterface to the user device, wherein the device overview interfacecomprises two or more of: (i) a device identifier, (ii) a sterilizationcycle summary, (iii) a sterilization cycle table, or (iv) asterilization cycle visualization.

Example 52

The processing component network of Example 51, wherein thesterilization cycle summary comprises a total number of cycles, anaverage cycles per day, and a number of cycles including a biologicalindicator; wherein the sterilization cycle table comprises a set ofrows, each row corresponding to a single sterilization cycle performedby the sterilizing cabinet; and wherein the sterilization cyclevisualization comprises one or more of a pie chart, a bar chart, or agraph.

Example 53

The processing component network of any one or more of Examples 44through 52, wherein the first medical device processing componentcomprises a biological indicator analyzer, and wherein the instructionsto provide the set of device information comprise instructions toprovide a device overview interface to the user device, wherein thedevice overview interface comprises two or more of: (i) a deviceidentifier, (ii) a biological indicator analysis summary, (iii) anindicator well status, or (iv) an indicator analysis table.

Example 54

The processing component network of Example 53, wherein the biologicalindicator analysis summary comprises a total number of analyses, anumber of analyses per day, and a number of analyses indicating cyclesuccess; wherein the indicator well status comprises a plurality of wellindicators, each well descriptor comprising a vacancy indicator and ananalyses duration indicator; and wherein the indicator analysis tablecomprises a set of rows, each row corresponding to a single biologicalindicator analysis performed by the biological indicator analyzer.

Example 55

A method for monitoring and managing a network of medical deviceprocessing components comprising the steps: (a) creating a site record;(b) creating a device record for a first medical device processingcomponent and associating the device record with the site record; (c)connecting the first medical device processing component to acommunication hub via a network interface of the communication hub; (d)receiving a site selection identifying the site record from a userdevice and, in response, providing a list of devices associated with thesite record to the user device; (e) receiving a device selectionidentifying the device record from the user device and, in response,providing a set of device information associated with the first medicaldevice processing component to the user device; (f) receiving, at thecommunication hub, a task record from the first medical deviceprocessing component, the task record describing a first task performedby the first medical device processing component; and (g) providing thetask record to a second medical device processing component, wherein thesecond medical device processing component is configured to perform asecond a second task based upon the task record.

Example 56

The method of Example 55, wherein the act of connecting the firstmedical device processing component to the communication hub comprises:(i) receiving a device connection request from the user device, (ii)causing the user device to display a connection interface, (iii)receiving a set of device connection information from the user device,and (iv) attempting a connection to the first medical device processingcomponent using the set of device connection information; and whereinthe connection interface comprises a set of connection instructions.

Example 57

The method of Example 56, wherein the connection interface is configuredto provide to the communication hub: (i) a network location identifier,a username, and a password, or (ii) a network pairing code.

Example 58

The method of any one or more of Examples 55 through 57, wherein thefirst medical device processing component comprises a sterilizingcabinet, wherein providing the set of device information comprisescausing a device overview interface to display on the user device,wherein the device overview interface comprises two or more of: (i) adevice identifier, (ii) a sterilization cycle summary, (iii) asterilization cycle table, and (iv) a sterilization cycle visualization.

Example 59

The method of Example 58, wherein the sterilization cycle summarycomprises a total number of cycles, an average cycles per day, and anumber cycles including a biological indicator; wherein thesterilization cycle table comprises a set of rows, each rowcorresponding to a single sterilization cycle performed by the firstmedical device processing component; and wherein the sterilization cyclevisualization comprises one or more of a pie chart, a bar chart, or agraph.

Example 60

The method of any one or more of Examples 55 through 59, wherein thefirst medical device processing component comprises a biologicalindicator analyzer; wherein providing the set of device informationcomprises causing a device overview interface to display on the userdevice; wherein the device overview interface comprises two or more of:(i) a device identifier, (ii) a biological indicator analysis summary,(iii) an indicator well status, and (iv) an indicator analysis table.

Example 61

The method of Example 60, wherein the biological indicator analysissummary comprises a total number of analyses, a number of analyses perday, and a number of analyses indicating cycle success; wherein theindicator well status comprises a plurality of well indicators, eachwell descriptor comprising a vacancy indicator and an analyses durationindicator; and wherein the indicator analysis table comprises a set ofrows, each row corresponding to a single biological indicator analysisperformed by the indicator analyzer.

Example 62

A processing component network comprising: (a) a set of medical deviceprocessing components comprising: (i) a sterilizing cabinet, and (ii) abiological indicator analyzer; and (b) a means for configuring a networkand monitoring medical device processing components; wherein the meansfor monitoring the set of medical device processing components isconfigured to: (i) connect to the set of medical device processingcomponents, and (ii) display a set of device information generated by atleast one device of the set of medical device processing components.

Example 63

The processing component network of Example 62, further comprising ameans for providing communication between the set of medical deviceprocessing components.

Example 64

A method of processing a medical device, the method comprising: (a)receiving input from a user selecting a sterilization cycle from aplurality of available sterilization cycles; (b) identifying abiological indicator associated with the selected sterilization cycle;(c) prompting the user via a touch screen display to place the medicaldevice and the biological indicator into a sterilization chamber of asterilizing cabinet; (d) performing load conditioning on the medicaldevice in the sterilization chamber; and (e) performing the selectedsterilization cycle on the medical device in the sterilization chamberafter completing the act of load conditioning.

Example 65

The method of Example 64, further comprising presenting the user withinformation regarding each of the available sterilization cycles via thetouch screen.

Example 66

The method of any one or more of Examples 64 through 65, furthercomprising receiving an indicator data set from a reader of thesterilizing cabinet based on the user's use of the reader to read anidentification tag of the biological indicator.

Example 67

The method of Example 66, wherein the indicator data set comprises anindicator type, further comprising restricting the plurality ofavailable sterilization cycles based upon the indicator type.

Example 68

The method of any one or more of Examples 66 through 67, wherein theindicator data set comprises an indicator expiration date, the methodfurther comprising prompting the user to obtain a new biologicalindicator when the indicator expiration date indicates that thebiological indicator has expired.

Example 69

The method of any one or more of Examples 66 through 68, wherein theindicator data set comprises an indicator recall status, the methodfurther comprising prompting the user to obtain a new biologicalindicator when the indicator recall status indicates that the biologicalindicator has been recalled by a provider.

Example 70

The method of any one or more of Examples 66 through 69, wherein theindicator data set comprises an indicator source, the method furthercomprising prompting the user to obtain a new biological indicator whenthe indicator source is not within a set of approved indicator sources.

Example 71

The method of any one or more of Examples 64 through 70, furthercomprising prompting the user via the touch screen display to use areader of the sterilizing cabinet to read an identification tag of thebiological indicator.

Example 72

The method of Example 71, further comprising displaying a soft indicatorrequirement on the touch screen display when: (i) the sterilizingcabinet has not read the identification tag of the biological indicator,and (ii) the sterilizing cabinet has received an indication from theuser that the sterilization cycle should begin.

Example 73

The method of any one or more of Examples 71 through 72, furthercomprising displaying a hard indicator requirement on the touch screendisplay when: (i) the sterilizing cabinet has not read theidentification tag of the biological indicator, and (ii) the sterilizingcabinet has received an indication from the user that the sterilizationcycle should begin, wherein the hard indicator requirement prevents thesterilization cycle from being performed.

Example 74

The method of Example 73, further comprising removing the hard indicatorrequirement when: (i) the sterilizing cabinet reads the identificationtag of the biological indicator, or (ii) the sterilizing cabinetreceives a bypass code from the user.

Example 75

The method of any one or more of Examples 64 through 74, furthercomprising displaying via the touch screen display a load placementimage, wherein the load placement image comprises: (i) a location forone or more surgical instruments, and (ii) a location for the biologicalindicator.

Example 76

The method of any one or more of Examples 64 through 75, wherein the actof performing load conditioning comprises one or more of: (i) removingmoisture from the medical device, and (ii) raising the temperaturewithin the sterilizing chamber.

Example 77

The method of any one or more of Examples 64 through 76, furthercomprising: (a) receiving a set of placement data from a placementsensor of the sterilizing cabinet, wherein the set of placement dataindicates the location of the medical device and the biologicalindicator; and (b) determining whether to perform the sterilizationcycle based upon the set of placement data.

Example 78

A sterilizing cabinet for sterilizing a medical device comprising aprocessor, a sterilization chamber, and a touch screen display, whereinthe processor is configured to execute instructions to: (a) display aset of sterilization cycles; (b) receive a sterilization cycleselection; (c) display a biological indicator type based upon thesterilization cycle selection, wherein the biological indicator typeindicates a biological indicator associated with the sterilization cycleselection; (d) display a set of placement instructions, wherein the setof placement instructions comprises a location for the medical deviceand a location for a biological indicator; (e) perform a loadconditioning process on the medical device in the sterilization chamber;and (f) perform a sterilization cycle on the medical device in thesterilization chamber based upon the sterilization cycle selection.

Example 79

The sterilizing cabinet of Example 78, further comprising a reader,wherein the processor is further configured to receive an indicator dataset from the reader when a user uses the reader to read anidentification tag of the biological indicator.

Example 80

The sterilizing cabinet of Example 79, wherein the indicator data setcomprises an indicator expiration date, wherein the processor is furtherconfigured to execute instructions to display information indicatingthat the biological indicator has expired when the indicator expirationdate indicates that the biological indicator has expired.

Example 81

The sterilizing cabinet of any one or more of Examples 79 through 80,wherein the indicator data set comprises an indicator recall status,wherein the processor is further configured to execute instructions todisplay information indicating that the biological indicator isdefective when the indicator recall status indicates that the biologicalindicator has been recalled by a provider.

Example 82

The sterilizing cabinet of any one or more of Examples 79 through 81,wherein the indicator data set comprises an indicator source, whereinthe processor is further configured to execute instructions to displayinformation indicating that the biological indicator is incompatiblewhen the indicator source is not within a set of approved indicatorsources.

Example 83

A sterilizing cabinet comprising: (a) a sterilization chamber; (b) atouch screen display; (c) a biological indicator reader; and (d) a meansfor guiding a user through the process of selecting a sterilizationcycle, selecting a verified biological indicator, placing a medicaldevice in the sterilization chamber, placing the biological indicator inthe sterilization chamber, and initiating the sterilization cycle.

Example 84

A method for analyzing a biological indicator with an indicatoranalyzer, the method comprising: (a) presenting instructions to a uservia a touch screen of the indicator analyzer; (b) receiving a biologicalindicator in a well selected from a plurality of wells in the indicatoranalyzer; (c) analyzing the biological indicator in the selected well,wherein the act of analyzing comprises evaluating fluorescenceassociated with the biological indicator in the selected well; (d)displaying results of the analysis via the touch screen; and (e) if theresults of the analysis indicate that the biological indicator is notsterile, initiating a quarantine procedure.

Example 85

The method of Example 84, wherein verifying the control status of abiological indicator analysis comprises: (i) identifying a lotassociated with the biological indicator, (ii) determining whether acontrol has been performed on the lot, and (iii) if the control has notbeen performed on the lot, then perform the following: (A) display aninstruction for a user to place a control indicator in a well of thebiological indicator analyzer, (B) perform a control analysis on thecontrol, (C) if the control analysis fails the first time, then displayan instruction for the user to repeat verifying the control status ofthe biological indicator using a different well, and (D) if the controlanalysis fails for the second time, then display an instruction for theuser to repeat verifying the control status of the biological indicatorusing a different lot.

Example 86

The method of any one or more of Examples 84 through 85, whereinperforming the biological indicator analysis comprises: (i) displayingan instruction for a user to verify that the biological indicator hasundergone a sterilization cycle, (ii) displaying an instruction for auser to verify chemical activation of the biological indicator, (iii)determining whether the biological indicator has been placed in a wellof the indicator analyzer, (iv) incubating the biological indicator, (v)emitting light towards the biological indicator from a light source ofthe indicator analyzer, and (vi) detecting fluorescence from thebiological indicator using a sensor of the indicator analyzer.

Example 87

The method of any one or more of Examples 84 through 86, wherein thequarantine procedure comprises: (i) identifying a set of potentiallycontaminated medical devices, and (ii) for each potentially contaminatedmedical device of the set of the potentially contaminated medicaldevices, provide a notification to a responsible party for thatpotentially contaminated medical device.

Example 88

The method of claim 84, further comprising: (a) displaying aninstruction for a user to scan the biological indicator using anindicator scanner of the indicator analyzer; (b) receiving an indicatoridentification from the biological indicator; and (c) determining anindicator data set based upon the indicator identification, wherein theindicator data set comprises a unique identifier and an indicatorhistory.

Example 89

A method for analyzing a biological indicator with an indicatoranalyzer, the method comprising: (a) verifying a control status of abiological indicator analysis by: (i) identifying a lot associated withthe biological indicator, (ii) determining whether a control has beenperformed on the lot, and (iii) if the control has not been performed onthe lot, the performing the following: (A) display an instruction for auser to place a control indicator in a well of the biological indicatoranalyzer, (B) perform a control analysis on the control, (C) if thecontrol analysis fails the first time, then display an instruction forthe user to repeat verifying the control status of the biologicalindicator using a different well, and (D) if the control analysis failsfor the second time, then display an instruction for the user to repeatverifying the control status of the biological indicator using adifferent lot; (b) performing the biological indicator analysis by: (i)displaying an instruction for a user to verify that the biologicalindicator has undergone a sterilization cycle, (ii) displaying aninstruction for a user to verify chemical activation of the biologicalindicator, (iii) determining whether the biological indicator has beenplaced in a well of the indicator analyzer, (iv) incubating thebiological indicator, (v) emitting light toward the biological indicatorfrom a light source of the indicator analyzer, and (vi) detectingfluorescence from the biological indicator using a sensor of theindicator analyzer; (c) distributing results of the biological indicatoranalysis; and (d) if the results of the biological indicator analysisindicate that the biological indicator is not sterile, then initiating aquarantine procedure.

Example 90

A biological indicator analyzer, comprising: (a) a plurality of wells,wherein each well is configured to receive a respective biologicalindicator; (b) a plurality of organism detector features, wherein eachorganism detector feature is configured to detect whether a biologicalindicator disposed in a corresponding well of the plurality of wellscontains a living organism; and (c) a touch screen, wherein the touchscreen is configured to receive user input and provide information tothe user indicating a status of biological indicator analysis.

Example 91

The biological indicator analyzer of Example 90, further comprising anindicator scanner, wherein the indicator scanner is operable to read anindicator identification from the biological indicator and determine anindicator data set based upon the indicator identification, wherein theindicator data set comprises a unique identifier and an indicatorhistory.

Example 92

The biological indicator analyzer of Example 91, wherein indicatorscanner is selected from the group consisting of an optical reader and awireless radio reader.

Example 93

The biological indicator analyzer of any one or more of Examples 90through 92, further comprising a processor and a communication port,wherein the processor is configured to provide an analysis result set toa server via the communication port, wherein the analysis resultcomprises a set of results data and the unique identifier.

Example 94

The biological indicator analyzer of any one or more of Examples 90through 93, further comprising a housing defining the wells andcontaining the organism detector features, wherein the housing providesbase configured to support the housing on a surface, wherein the touchscreen is oriented obliquely relative to the base.

X. Miscellaneous

It should be appreciated that any patent, publication, or otherdisclosure material, in whole or in part, that is said to beincorporated by reference herein is incorporated herein only to theextent that the incorporated material does not conflict with existingdefinitions, statements, or other disclosure material set forth in thisdisclosure. As such, and to the extent necessary, the disclosure asexplicitly set forth herein supersedes any conflicting materialincorporated herein by reference. Any material, or portion thereof, thatis said to be incorporated by reference herein, but which conflicts withexisting definitions, statements, or other disclosure material set forthherein will only be incorporated to the extent that no conflict arisesbetween that incorporated material and the existing disclosure material.

Having shown and described various embodiments of the present invention,further adaptations of the methods and systems described herein may beaccomplished by appropriate modifications by one of ordinary skill inthe art without departing from the scope of the present invention.Several of such potential modifications have been mentioned, and otherswill be apparent to those skilled in the art. For instance, theexamples, embodiments, geometrics, materials, dimensions, ratios, steps,and the like discussed above are illustrative and are not required.Accordingly, the scope of the present invention should be considered interms of the following claims and is understood not to be limited to thedetails of structure and operation shown and described in thespecification and drawings.

1. A method for monitoring and managing a network of medical deviceprocessing components comprising the steps: (a) creating a site record;(b) creating a device record for a first medical device processingcomponent and associating the device record with the site record; (c)connecting the first medical device processing component to acommunication hub via a network interface; (d) receiving a siteselection identifying the site record from a user device and, inresponse, providing a list of devices associated with the site record tothe user device; (e) receiving a device selection identifying the devicerecord from the user device and, in response, providing a set of deviceinformation associated with the first medical device processingcomponent to the user device; (f) receiving, at the communication hub, atask record from the first medical device processing component, the taskrecord describing a first task performed by the first medical deviceprocessing component; and (g) providing the task record to a secondmedical device processing component, wherein the second medical deviceprocessing component is configured to perform a second task based uponthe task record.
 2. The method of claim 1, wherein the act of connectingthe first medical device processing component to the communication hubcomprises: (i) receiving a device connection request from the userdevice; (ii) causing the user device to display a connection interface;(iii) receiving a set of device connection information from the userdevice; and (iv) attempting a connection to the first medical deviceprocessing component using the set of device connection information,wherein the connection interface comprises a set of connectioninstructions.
 3. The method of claim 2, wherein the connection interfaceis configured to provide to the communication hub: (i) a networklocation identifier, a username, and a password; or (ii) a networkpairing code.
 4. The method of claim 1, wherein the first medical deviceprocessing component comprises a sterilizing cabinet; wherein providingthe set of device information comprises causing a device overviewinterface to display on the user device, wherein the device overviewinterface comprises two or more of: (i) a device identifier; (ii) asterilization cycle summary; (iii) a sterilization cycle table; and (iv)a sterilization cycle visualization.
 5. The method of claim 4, whereinthe sterilization cycle summary comprises a total number of cycles, anaverage cycles per day, and a number of cycles including a biologicalindicator; wherein the sterilization cycle table comprises a set ofrows, each row corresponding to a single sterilization cycle performedby the first medical device processing component; and wherein thesterilization cycle visualization comprises one or more of a pie chart,a bar chart, or a graph.
 6. The method of claim 1, wherein the firstmedical device processing component comprises a biological indicatoranalyzer; wherein providing the set of device information comprisescausing a device overview interface to display on the user device;wherein the device overview interface comprises two or more of: (i) adevice identifier; (ii) a biological indicator analysis summary; (iii)an indicator well status; and (iv) an indicator analysis table.
 7. Themethod of claim 6, wherein the biological indicator analysis summarycomprises a total number of analyses, a number of analyses per day, anda number of analyses indicating cycle success; wherein the indicatorwell status comprises a plurality of well indicators, each welldescriptor comprising a vacancy indicator and an analyses durationindicator; and wherein the indicator analysis table comprises a set ofrows, each row corresponding to a single biological indicator analysisperformed by the indicator analyzer.
 8. The method of claim 1, whereinproviding the set of device information comprises causing a deviceoverview interface to display on the user device; wherein the deviceoverview interface comprises two or more of: (i) a device identifier;(ii) a biological indicator analysis summary; (iii) an indicator wellstatus; and (iv) an indicator analysis table.
 9. A processing componentnetwork comprising: (a) a set of medical device processing componentscomprising: (i) a sterilizing cabinet, and (ii) a biological indicatoranalyzer; and (b) a means for configuring a network and monitoringmedical device processing components; wherein the means for monitoringthe set of medical device processing components is configured to: (i)connect to the set of medical device processing components, and (ii)display a set of device information generated by at least one device ofthe set of medical device processing components.
 10. The processingcomponent network of claim 9, further comprising a means for providingcommunication between the set of medical device processing components.11. A method for monitoring and managing a network of medical deviceprocessing components comprising the steps: (a) connecting a firstmedical device processing component to a communication hub; (b)connecting a second medical device processing component to thecommunication hub; (c) in response to a request from a user device,providing a list of devices associated with the communication hub to theuser device; (d) in response to a request from a user device, providinginformation associated with the first and second medical deviceprocessing components to the user device; (e) performing a first taskwith the first medical device processing component; (f) receiving, atthe communication hub, a task record from the first medical deviceprocessing component, the task record describing the first task; (f)providing the task record to a second medical device processingcomponent; and (g) performing a second task with the second medicaldevice processing component.
 12. The method of claim 11, whereinconnecting the first medical device processing component to thecommunication hub comprises: (i) receiving a device connection requestfrom the user device; (ii) causing the user device to display aconnection interface; (iii) receiving a set of device connectioninformation from the user device; and (iv) attempting a connection tothe first medical device processing component using the set of deviceconnection information, wherein the connection interface comprises a setof connection instructions.
 13. The method of claim 12, wherein theconnection interface is configured to provide to the communication hub:(i) a network location identifier, a username, and a password; or (ii) anetwork pairing code.
 14. The method of claim 1, wherein the firstmedical device processing component comprises a sterilizing cabinet;wherein providing information associated with the first and secondmedical device processing components to the user device comprisescausing a device overview interface to display on the user device,wherein the device overview interface comprises two or more of: (i) adevice identifier; (ii) a sterilization cycle summary; (iii) asterilization cycle table; and (iv) a sterilization cycle visualization.15. The method of claim 14, wherein the sterilization cycle summarycomprises a total number of cycles, an average cycles per day, and anumber of cycles including a biological indicator; wherein thesterilization cycle table comprises a set of rows, each rowcorresponding to a single sterilization cycle performed by the firstmedical device processing component; and wherein the sterilization cyclevisualization comprises one or more of a pie chart, a bar chart, or agraph.
 16. The method of claim 11, wherein the first medical deviceprocessing component comprises a biological indicator analyzer; whereinproviding information associated with the first and second medicaldevice processing components to the user device comprises causing adevice overview interface to display on the user device; wherein thedevice overview interface comprises two or more of: (i) a deviceidentifier; (ii) a biological indicator analysis summary; (iii) anindicator well status; and (iv) an indicator analysis table.
 17. Themethod of claim 16, wherein the biological indicator analysis summarycomprises a total number of analyses, a number of analyses per day, anda number of analyses indicating cycle success; wherein the indicatorwell status comprises a plurality of well indicators, each welldescriptor comprising a vacancy indicator and an analyses durationindicator; and wherein the indicator analysis table comprises a set ofrows, each row corresponding to a single biological indicator analysisperformed by the indicator analyzer.
 18. The method of claim 11, whereinproviding information associated with the first and second medicaldevice processing components to the user device comprises causing adevice overview interface to display on the user device; wherein thedevice overview interface comprises two or more of: (i) a deviceidentifier; (ii) a biological indicator analysis summary; (iii) anindicator well status; and (iv) an indicator analysis table.